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Transforming the understanding
and treatment of mental illnesses.

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Featured Studies

Featured studies include only those currently recruiting participants. Studies with the most recent start date appear first.


Estrogen Variability and Irritability During the Menopause Transition

Study Type: Interventional
Start Date: June 15, 2022
Eligibility: Females, 45 Years to 55 Years, Accepts Healthy Volunteers
Location(s): Carolina Crossing B, Suite 1, Chapel Hill, North Carolina, United States

Women in the menopause transition (perimenopause) experience substantial day-to-day variability in estradiol and have a 2-4-fold increase in major depression risk. About 40% of perimenopausal women are susceptible to the emergence of affective symptoms tied to changes in estradiol. Among the perimenopausal women with affective impairment, most report irritability, not "depression," is their primary source of impairment and distress. The purpose of this research is to determine the neurophysiologic basis of susceptibility to estradiol fluctuations and irritability symptoms in perimenopausal women.


PET Imaging of Cyclooxygenase-2 in Multiple Sclerosis

Study Type: Interventional
Start Date: June 7, 2022
Eligibility: 18 Years to 99 Years, Does Not Accept Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

Multiple sclerosis (MS) is an autoimmune disease that has no cure. MRI is the main tool used in the study and treatment of people with MS. A tracer has been developed for cyclooxygenase-2 (COX-2), an enzyme found in the brain during inflammation. Researchers want to explore the role inflammation plays in MS and see if COX-2 is measurable in the brains of people with the disease.

Objective:

To see if COX-2 is detectable in the brains of individuals with MS.

Eligibility:

People ages 18 and older with MS who are otherwise healthy.

Design:

Participants will be screened with their medical history and a physical exam. They will have an EKG to check the electrical activity of the heart.

Participants study involvement requires 2 to 3 visits and will last between 1 week and 4 months.

Participants will have 2 PET scans of the brain. These might occur on the same day or on separate days. A small amount of a radioactive chemical will be injected through an intravenous catheter. A needle will be used to guide a thin plastic tube into an arm vein. The needle will be removed. Only the catheter will be left in the vein. The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. They will wear a plastic mask molded to fit the head. The scan will last about 90 minutes. Participants will receive the medication celecoxib orally about 2 hours before the second scan.

Participants will have blood tests.

Participants must avoid certain medications a month prior to the PET scans.

...


How Hormones and Exposure and Response Prevention (EX/RP) Affect the Brain of People With OCD

Study Type: Interventional
Start Date: May 31, 2022
Eligibility: 18 Years to 45 Years, Does Not Accept Healthy Volunteers
Location(s): University of Pennsylvania, Philadelphia, Pennsylvania, United States; New York State Psychiatric Institute, New York, New York, United States

Studies show that hormones affect the brain's fear extinction network, which is relevant for therapy involving exposure and response prevention (EX/RP), a first-line treatment for obsessive compulsive disorder (OCD). This study will examine the effect of delivering EX/RP to women during different phases in their menstrual cycle to determine the effects of hormones on the fear extinction network and on their OCD symptoms.


Characterization of an Optically Pumped Magnetometer (OPM) Magnetoencephalography (MEG) Array

Study Type: Interventional
Start Date: May 2, 2022
Eligibility: 18 Years to 65 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

Brain activity produces magnetic fields. These fields can be measured outside the head. Existing technology, called MEG, measures these fields. Researchers are testing a new type of magnetic field sensor called OPM. They hope it can help pinpoint with very high accuracy where brain activity is generated.

Objective:

To develop and test a new type of sensor for measuring the magnetic fields produced by brain activity.

Eligibility:

Healthy people ages 18-65 who had a magnetic resonance imaging (MRI) scan under protocol 17-M-0181.

Design:

Participants may be asked to complete sessions on both the traditional MEG instrument and the OPM array.

For the MEG, 3 small coils will be placed on the participant s face with tape. Their head will be positioned inside the MEG device.

For the OPM, sensors are housed in a 3d printed array. The sensors will be attached to a cap placed on the participant s head.

For both scans, participants will be seated in a chair inside a magnetically shielded room. They may complete several tasks. In one task, plastic cells will be placed on their fingers. Puffs of air will be sent to these cells, which will stimulate the sense of touch. Other tasks may include the following stimuli: visual (such as checkerboards), auditory (such as beeps and tones), or language (words and letters).

Researchers may also obtain recordings while they stimulate the nerve in the participant s forearm using electrical current in small electrodes.

Participation is expected to last for 1 day. Additional optional scans may be offered for up to 1 year....


Fear, Gastrointestinal Distress, and Interoception: Physiological and Psychological Mechanisms in Eating Disorders

Study Type: Interventional
Start Date: April 22, 2022
Eligibility: Females, 18 Years to 40 Years, Does Not Accept Healthy Volunteers
Location(s): Ohio University, Athens, Ohio, United States

The proposed study tests fear, gut peptide response, and perceptions of fullness as causes of gastrointestinal distress and eating disorder maintenance.


Brain and Meditation (BAM) Study

Study Type: Interventional
Start Date: April 13, 2022
Eligibility: 25 Years to 65 Years, Accepts Healthy Volunteers
Location(s): Center for Healthy Minds, Madison, Wisconsin, United States

This study is a randomized controlled trial to test the impact of an app-based meditation program on perceived stress and behavioral correlates of stress with known neurobiological correlates. Healthy adult participants between the ages of 25-65 will be enrolled in the study for about 4-5 months.


Modulation of Emotion Perception in Humans Via Amygdala Stimulation

Study Type: Interventional
Start Date: March 31, 2022
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States

This study will enroll patients with epilepsy who are being evaluated for epilepsy surgery and have intracranial EEG electrodes. In this study, the aim is to record brain signals from areas important in social and emotional processing and to understand how electrical brain stimulation - called neuromodulation - affects such processing. Patients enrolled in this study will be asked to view images depicting a variety of emotionally positive, negative, or neutral themes. As the patient views these images, a small amount of imperceptible and painless electric current will be used to map function of certain parts of a human brain. The overarching goal of the study is to determine if neuromodulation can be used in certain areas of the brain to treat cognitive disorders such as memory loss and post-traumatic stress disorder.


Systems Analysis and Improvement Approach to Optimize the Task-shared Mental Health Treatment Cascade (SAIA-MH)

Study Type: Interventional
Start Date: March 14, 2022
Eligibility: Age N/A, Does Not Accept Healthy Volunteers
Location(s): Rural Hospital Nhamatanda, Nhamatanda, Sofala, Mozambique; Urban Health Center Dondo Sede, Dondo, Sofala, Mozambique; Rural Health Center Mafambisse, Dondo, Sofala, Mozambique; Hospital Muxúngue, Chibabava, Sofala, Mozambique; Urban Health Center Mascarenhas, Beira, Sofala, Mozambique; Urban Health Center Macurungo, Beira, Sofala, Mozambique; Urban Health Center Inhamizua, Beira, Sofala, Mozambique; Urban Health Center Chingussura, Beira, Sofala, Mozambique; Rural Health Center Vanduzi, Vanduzi, Manica, Mozambique; Rural Health Center Sussundenga Sede, Sussundenga, Manica, Mozambique; Rural Health Center Macate, Macate, Manica, Mozambique; District Hospital Gondola, Gondola, Manica, Mozambique; Urban Health Center Vila Nova, Chimoio, Manica, Mozambique; Urban Health Center Nhamaonha, Chimoio, Manica, Mozambique; District Hospital Catandica, Catandica, Manica, Mozambique; District Hospital Manica, Manica, Mozambique

The purpose of this study is to test the effectiveness of a multicomponent implementation strategy entitled the Systems Analysis and Improvement Approach for mental health (SAIA-M) using a cluster randomized trial at the health facility level. SAIA-MH focuses on improving the mental health treatment cascade in primary outpatient mental healthcare. The mental health treatment cascade is a model that outlines the sequential, linked treatment steps that people with mental illness must navigate, from initial diagnosis to symptom/function improvement.

This study will also assess the potential mechanisms by which the SAIA-MH implementation strategy works, or does not work, along with the cost and effectiveness of scaling-up SAIA-MH in Mozambique.


Supporting Treatment Access and Recovery in COD

Study Type: Interventional
Start Date: March 11, 2022
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Right Choice Health Group, Fitchburg, Massachusetts, United States; Right Choice Health Group, Worcester, Massachusetts, United States

This 4-year study will randomize 1,000 people with co-occurring opioid use and mental health disorders (COD) at medication for opioid use disorder (MOUD) clinics to evaluate the effectiveness of MISSION, a multi-component team approach, or its components with MOUD versus MOUD alone, as well as the incremental benefits of MISSION or its components for improving outcomes. We expect that individuals receiving MISSION or its parts + MOUD will show greater improvement over MOUD alone on: engagement, substance use, and mental health.


Examining the Impact of Family Connectors

Study Type: Interventional
Start Date: March 7, 2022
Eligibility: 18 Years to 85 Years, Accepts Healthy Volunteers
Location(s): NYU Langone Health, New York, New York, United States

The purpose of this study is to understand the impact of Family Connectors, a peer-to-peer support and education program for family members who have participated in OnTrackNY, a treatment program for adolescents and young adults.


Optimizing Engagement in Services for First-Episode Psychosis

Study Type: Interventional
Start Date: March 1, 2022
Eligibility: 15 Years to 35 Years, Does Not Accept Healthy Volunteers
Location(s): San Fernando Mental Health Center, Granada Hills, California, United States; Olive View - UCLA Medical Center, Sylmar, California, United States

This study will compare a 12-session behavioral activation (BA) intervention modified for first-episode psychosis (FEP) to usual community mental health care (i.e., treatment-as-usual; TAU) delivered over 6 months with a sample of Latinos with FEP and their families. Comparable family group sessions will also be delivered to participants in both conditions. It is expected that BA participants will show better engagement than TAU participants.


Theta Connectivity in Working Memory

Study Type: Interventional
Start Date: January 24, 2022
Eligibility: 18 Years to 65 Years, Accepts Healthy Volunteers
Location(s): University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

The participants will perform a cognitive control task. During the task, rhythmic trains of transcranial magnetic stimulation will be delivered to the prefrontal cortex and parietal cortex. Participants will be screened for their ability to perform the task. Magnetic resonance imaging will be used to localize regions of interest to be targeted. Electroencephalography will be collected concurrent with stimulation.


Prevention and Early Identification for High Risk Youth in School-based Clinics

Study Type: Interventional
Start Date: January 3, 2022
Eligibility: 12 Years to 21 Years, Accepts Healthy Volunteers
Location(s): CHA Teen Health Center at Everett High School, Everett, Massachusetts, United States; CHA Health Equity Research Lab, Cambridge, Massachusetts, United States; CHA-Teen Health Center at Cambridge Rindge and Latin School, Cambridge, Massachusetts, United States

The proposed research project provides a novel approach to screening, early assessment, and preventive interventions for high-risk youth in racial/ethnic/linguistically (REL)-diverse communities.

The investigators assess a health promotion intervention as a way of reducing treatment disparities in REL-minority youth. This population is underrepresented in child psychiatry research. It is often excluded from clinical trials of medication or therapy because of challenges with transportation, literacy, resources or other issues. The study will take place during or following a health care crisis and economic recession, making findings relevant to understanding the mechanisms by which hardship translates into youth mental illness. The innovative integration of online screening into school-based clinics in REL-minority communities is made possible by the combination of access to a new technology (CAT) in the context of a learning health community serving an REL-minority population. Empirical research on the impact of a resilience-based prevention intervention in youth and youth at risk is both innovative and much needed during this period of health, social and economic crisis.


A Multimodal Parent-focused Intervention for Vulnerable Populations in the Bronx

Study Type: Interventional
Start Date: December 17, 2021
Eligibility: 18 Years to 65 Years, Does Not Accept Healthy Volunteers
Location(s): PRIME, Bronx, New York, United States

For caregivers in the Bronx, the pandemic has caused unprecedented psychological distress; in addition to combating social determinants of health (SDOH), these families now face greater financial insecurity and challenges related to their school-aged children. Furthermore, social distancing requirements and limited telehealth resources for Bronx families have posed greater barriers to healthcare. Such parental distress contributes to heightened risk of transgenerational cycles of psychological stress, trauma and maltreatment. The social and economic impacts of the COVID-19 pandemic have had significant consequences for family well-being, putting parents at higher risk of experiencing distress and potentially impairing their ability to provide supportive care to their children. Although children may be less susceptible to the most damaging physical consequences of COVID-19, there are growing concerns regarding the short-and long-term impacts of pandemic-related stressors on children. The marked upheaval of family life over an extended period may make children vulnerable to mental health consequences associated with the public health crisis and infection mitigation efforts. School and childcare closures, unstable financial circumstances, social isolation and lack of support have a disproportionate, cumulative impact on parents and may undermine their capacities to provide support for their children. Importantly, a large body of evidence suggests that parental stress during times of disasters induces psychopathologies in family members including children. Further, high anxiety and depressive symptoms in parents during the pandemic have been associated with higher child abuse potential, whereas greater parental support was associated with lower perceived stress and child abuse potential. In addition to psychological impacts, stress associated with caregiving can interfere with parents' ability to maintain their own health. This multimodal study addresses key strategies to mitigate the psychological and health impact of COVID-19 in parents.


Opioids and Social Support Enhanced Extinction Effects

Study Type: Interventional
Start Date: December 13, 2021
Eligibility: 18 Years to 35 Years, Accepts Healthy Volunteers
Location(s): UCLA Department of Psychology, 5514 Pritzker Hall, Los Angeles, California, United States; UCLA, Los Angeles, California, United States

University of California, Los Angeles researchers will recruit healthy participants (age 18-35) to participate in a study examining whether the administration of naltrexone, an opioid antagonist, eliminates the ability of social support figure reminders to enhance fear extinction--a process during which a threatening cue is learned to not predict a negative or threatening outcome (i.e., electric shock) by being repeatedly presented in the absence of that outcome.

After undergoing an email screening, a telephone screening, an in lab screening, and a health screening, 60 participants will be enrolled in the study. During the experiment, 30 participants will be administered naltrexone and 30 participants will be administered placebo (both participants and experimenters will be blind to condition) before undergoing a fear extinction procedure in which threatening cues--cues that predict electric shock--will be paired with either an image of a social support figure (provided by participants) or a second threatening cue. These pairings will be presented repeatedly in the absence of shock in order for fear extinction to occur. Participants will return for a follow-up test to determine if fear extinction was successful.


Dose Response Relationship of Oxytocin on Irritability in Youths

Study Type: Interventional
Start Date: December 1, 2021
Eligibility: 14 Years to 18 Years, Does Not Accept Healthy Volunteers
Location(s): University of Nebraska Medical Center Department of Psychiatry, Omaha, Nebraska, United States

The proposed study is a randomized, double-blind proof of concept (PoC) study on the neural impact of intranasal oxytocin (OXT) administration for adolescents (age 14 to 18), demonstrating a clinically significant level of irritability as defined by a score of ≥4 on the Affective Reactivity Index (ARI). Planned enrollment is 80 subjects over 3 years.


Electrophysiologic Sleep Phenotyping and Sleep-Dependent Neuro-maturation in Clinical and Healthy Pediatric Populations

Study Type: Observational
Start Date: November 9, 2021
Eligibility: 8 Years and Younger, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

During the first few decades of life, the brain changes dramatically in shape and function. Sleep lets researchers measure these changes. Researchers want to create a database of sleep and neurodevelopmental data in a group of infants and children to learn more.

Objective:

To address a knowledge and data gap in the field of sleep and neurodevelopment in infants and children.

Eligibility:

Children ages 6 months to 76 months who may or may not be at risk for neurodevelopmental and neuropsychiatric disorders. Also, children ages 6 months to 8 years who have a referral for a sleep study.

Design:

Participants will have neurodevelopmental testing. They will have a medical, psychiatric, and family history. They will have a physical and neurological exam. They will be interviewed and complete surveys. They will give a cheek swab and/or blood sample.

Some participants will have 1 study visit that lasts 2 days.

Other participants will have up to 4 study visits. Each visit will last 2 days. Visits occur every 8 months to 1 year, for a total participation time of 2 years.

Participants will have a 20-minute daytime electroencephalogram (EEG), if possible. This EEG session will be used to calibrate the machine for the overnight study.

Participants will take part in an inpatient overnight sleep study. Electrodes will be placed on the participants. For young children, parents will help place the EEG leads. Other sensors may also be placed. A gauze cap will be placed on participants head to protect the leads and keep the participants from moving them. 'Lights out' will occur as close to participants bedtime as possible.


Supporting Refugee and Immigrant Youth's Mental Health

Study Type: Interventional
Start Date: November 4, 2021
Eligibility: 8 Years to 18 Years, Accepts Healthy Volunteers
Location(s): Loyola University Chicago, Chicago, Illinois, United States

The purpose of this study is to examine the effectiveness of STRONG on the mental health of refugee and immigrant students using a group randomized waitlist control design (e.g., randomization by school/group). Further, the impact of STRONG on key target mechanisms (e.g., resilience, coping, and school connectedness) are also examined. Finally, investigators examine the implementation of STRONG to guide additional dissemination. School-based mental health clinicians will co-facilitate STRONG groups in schools, meeting once a week. STRONG will be implemented in six public schools across two academic years. In each school, one group of approximately five students will be implemented, resulting in a sample of 60 students total across the two years. Schools will be randomly assigned to either provide the STRONG program immediately (immediate treatment) or after three months (delayed treatment). A team of 10 undergraduate students and four graduate students will collect data at baseline and at three- and six-months post baseline.

Aim 1: Evaluate impact of STRONG on student mental health via randomized waitlist control design.

1) Investigators hypothesize that students who participate in STRONG will show improvements in self-reported, parent-reported, and teacher-reported mental health (emotional symptoms, conduct problems, hyperactivity/inattention, and peer problems) as compared to the waitlist control group (primary outcome).

Aim 2: Examine the impact of STRONG on resilience, coping, and school connectedness and how these changes are related to student mental health outcomes.

Investigators hypothesize that students who participate in STRONG will show improvements in self-reported resilience, coping efficacy, school connectedness, and parent-reported coping as compared to the waitlist control group (target mechanisms). Investigators hypothesize that these changes will be related to student mental health improvement/maintenance over time (mechanism of action).

Aim 3: Examine implementation of STRONG across schools.

Investigators will conduct focus groups with clinicians and interviews with school personnel (teachers, administrators) to examine the challenges and successes related to implementation of STRONG. Qualitative thematic analysis will be conducted. Satisfaction (clinician, parent, and student), student engagement with each session, and fidelity ratings will be examined.


Virtual Mom Power With High-Adversity Mothers and Children (MPHAMC)

Study Type: Interventional
Start Date: November 1, 2021
Eligibility: 3 Years and Older, Accepts Healthy Volunteers
Location(s): Tulane Child and Family Lab, New Orleans, Louisiana, United States

This study is a randomized controlled confirmatory efficacy trial of virtual Mom Power (MP), a group-based, relationship-focused multifamily preventive intervention.


Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers

Study Type: Interventional
Start Date: October 18, 2021
Eligibility: 18 Years and Older, Accepts Healthy Volunteers
Location(s): University of New Mexico, Albuquerque, New Mexico, United States

This study tests the effectiveness of a community-based peer advocacy, mutual learning, and social support intervention (Refugee and Immigrant Well-being Project) to reduce several negative consequences of the COVID-19 pandemic that are disproportionately impacting Latinx and Black populations: psychological distress, financial problems, and daily stressors. In partnership with five community-based organizations that focus on mental health, legal, education, and youth issues with Latinx immigrants and African refugees, we will also be able to examine the effects of people's involvement with community-based organizations and local and state policy changes on their mental health, economic stability, stressors, and social support. This is important not only for Latinx and Black populations and the large number of immigrants and refugees in the United States and worldwide, but also because the intervention model and what we learn from this study have the potential to alleviate mental health disparities experienced by other marginalized populations who face unequal access to social and material resources, disproportionate exposure to trauma and stress, and worse consequences of the COVID-19 pandemic.


Multi-level Determinants of Implementation and Sustainment in the Education Sector

Study Type: Interventional
Start Date: October 13, 2021
Eligibility: 5 Years and Older, Accepts Healthy Volunteers
Location(s): University of Florida, Gainesville, Florida, United States; Virginia Commonwealth University, Richmond, Virginia, United States

The purpose of this study is to learn more about teachers' sustainment of use of core components of BEST in CLASS in a follow-up study.


Feedback and Outcomes for Clinically Useful Student Services (FOCUSS)

Study Type: Interventional
Start Date: August 17, 2021
Eligibility: 18 Years and Older, Accepts Healthy Volunteers
Location(s): West Haven Public Schools, West Haven, Connecticut, United States

The purpose of the study is to examine the implementation outcomes (i.e., feasibility, appropriateness, acceptability, and fidelity) of MBC in school-based mental health treatment services. The investigators plan to observe the effectiveness of MBC on student engagement and treatment outcomes as a secondary goal. This pilot implementation-effectiveness trial is designed to inform a future, large-scale trial with more participants.


EPI-MINN: Targeting Cognition and Motivation

Study Type: Interventional
Start Date: August 12, 2021
Eligibility: 15 Years to 40 Years, Does Not Accept Healthy Volunteers
Location(s): University of Minnesota, Minneapolis, Minnesota, United States; Hennepin Healthcare, Minneapolis, Minnesota, United States; Human Development Center, Duluth, Minnesota, United States

The purpose of this study is to perform a practice-based research project designed to assess whether cognition and motivated behavior in early psychosis can be addressed as key treatment goals within real-world settings by using a 12-week mobile intervention program. Participants who are enrolled in a chart review study of measurement-based care will be recruited to participate in this study. In the measurement-based care study, participants are enrolled in coordinated specialty care programs for early psychosis that provide comprehensive clinical services such as psychotherapy, medication management, psychoeducation, work or education support, and measurement-based care. Participants will complete a set of well- defined measures every 6 months that assess symptoms, functioning, cognition and motivation as standard of care. The current study will utilize the data acquired in the measurement-based care study.

The aim of this study is to investigate a well-defined 12-week mobile intervention program specifically designed to target cognitive functioning and motivated behavior for individuals with early psychosis. The investigators will test for differences in the clinical trajectories over 18 months in those who receive the intervention vs. those who do not.


11C-YJH08 PET Imaging for the Detection of Glucocorticoid Receptor Expression in Patients With Metastatic Prostate Cancer

Study Type: Interventional
Start Date: August 10, 2021
Eligibility: Males, 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): University of California San Francisco, San Francisco, California, United States

This phase I trial studies if positron emission tomography (PET) imaging using 11C-YJH08 can be useful for detecting certain cell receptor expression in tumor cells in patients with prostate cancer that has spread to other parts of the body (metastatic). 11C-YJH08 is a small-molecule radiotracer that binds to receptors on cells (glucocorticoid receptor) so that they show up better on the PET scan. Anti-hormone therapy (including enzalutamide) can cause more glucocorticoid receptors to be produced in tumor cells, which can make the tumor cells resist hormone therapies. If researchers can find a better way to detect whether glucocorticoid receptors are increasing during therapy, it may lead to more successful therapies using glucocorticoid receptor antagonists.


cTBS/fMRI Study of Hierarchical Control in the PFC

Study Type: Interventional
Start Date: July 23, 2021
Eligibility: 18 Years to 30 Years, Accepts Healthy Volunteers
Location(s): Florida State University Psychology Department Building, Tallahassee, Florida, United States; FSU MRI Facility, Tallahassee, Florida, United States

The objective of this study is to examine the effect of transcranial magnetic stimulation (TMS) on the prefrontal cortex and posterior parietal cortex.


Toward a Computationally-Informed, Personalized Treatment for Hallucinations

Study Type: Interventional
Start Date: July 15, 2021
Eligibility: 18 Years to 65 Years, Does Not Accept Healthy Volunteers
Location(s): Connecticut Mental Health Center, New Haven, Connecticut, United States

Auditory hallucinations are among the most distressing aspects of psychotic illness, and between 10 and 30% of people with hallucinations do not respond to antipsychotic medications. The authors have used computational modeling of behavior to link brain activity to development of auditory hallucinations in the hope of guiding new treatment development. The proposed studies take the first step toward individualized treatment approaches to hallucinations by attempting causal, pharmacological manipulation of relevant model parameters underlying these phenomena.


Goal Elicitation, Treatment Prioritization, & Electronically-Practiced Discussion for Psychiatry

Study Type: Interventional
Start Date: April 20, 2021
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Sandra Eskenazi Mental Health Center, Indianapolis, Indiana, United States

GET PrEPD-Psychiatry is a mixed-methods, developmental study to adapt a shared decision making (SDM) intervention to be specific for psychiatry decisions (Aim 1, previously completed), evaluate its feasibility and acceptability (Aim 2), and examine potential mechanisms of change and preliminary outcomes (Aim 3) of this innovative intervention to increase SDM and self-management for adults with serious mental illness (SMI). In line with National Institute of Mental Health (NIMH) priorities, we are examining whether GET PrEPD-Psychiatry engages the target mechanisms that putatively underlie the intervention (i.e., patient activation and communication self-efficacy; Aim 3). Aim 1 used approximately 200 deidentified transcripts from our prior study of SDM in psychiatry to cull language used in decision-making. These conversations were then used to program the Virtual Provider to represent common interactions and decisions in psychiatric visits. Iterative testing of the use of the Virtual Provider has been completed and feedback was obtained from our psychiatry consultants to refine the program. For Aim 2, we will recruit up to 40 patients to participate in GET PrEPD-Psychiatry (4 weekly goal setting/coaching sessions, coupled with Virtual Provider training and practice). We will assess participant satisfaction and utility ratings, as well as track their use (frequency and time-on-task) of the Virtual Provider program. For Aim 3, we will follow those 40 participants, interviewing them and observing SDM in sessions with their providers at baseline and approximately 3 months later. We hypothesize that participants will have significantly 1) improved mechanisms of change, demonstrated by increases in self-reported activation and communication self-efficacy, 2) improved SDM based on coded audio-recorded clinic visits, and 3) improved self-management and recovery attitudes.


A Mightier Healthcare System

Study Type: Interventional
Start Date: March 10, 2021
Eligibility: 8 Years to 12 Years, Does Not Accept Healthy Volunteers
Location(s): Neuromotion Inc, Boston, Massachusetts, United States

Access to effective pediatric mental health treatment is a major public health concern in the United States as paucity of pediatric providers leading to long wait times, financial burden, and stigma pose significant barriers to treatment. Digital mental health promises to remedy many chronic problems faced in providing timely and accessible mental health interventions to children. With that in mind, the investigators and Neuromotion Inc. created Mightier, an app-based heart rate biofeedback videogame platform designed to teach and facilitate practice of emotional regulation skills. The technology behind Mightier is backed by three trials showing clinical efficacy and since commercial launch 75% of families who have engaged with the product report improvement. However, Neuromotion's core mission remains increasing access to care, and the direct-to-consumer distribution of digital health also faces access challenges. The investigators propose that access to effective digital mental health interventions can be increased by meeting families where they already know to seek care: the traditional healthcare system. The investigators have partnered with a nationwide behavioral health insurance provider to pilot the integration of Mightier with traditional healthcare. Families will be recruited via direct outreach, social media, or healthcare provider referral. Participating children will be randomized into Mightier or treatment as usual control groups for 6 months. Behavioral healthcare utilization will be observed for 12 months. Through this work the investigators will demonstrate the value of Mightier to various stakeholders via decreased long-term healthcare utilization, confirm that Mightier use results in decreased symptoms of emotional dysregulation, irritability, and parent stress, and explore relationships among Mightier use, healthcare utilization, and symptoms. Ultimately this work will pave the way forward for large scale integration of digital healthcare and more traditional healthcare avenues while simultaneously increasing Mightier's ability to reach children in need.


Mobile Health (mHealth) Tools to Improve Delivery Quality of a Family Home Visiting Intervention

Study Type: Interventional
Start Date: January 27, 2021
Eligibility: 6 Months to 65 Years, Accepts Healthy Volunteers
Location(s): University of Makeni, Makeni, Sierra Leone

The proposed exploratory research will pilot a family-focused, behavioral health intervention while also developing and piloting innovative and cost-effective mHealth tools to support Community Health Workers (CHWs) in Sierra Leone. This dual focus will help build capacity both for delivery of evidence-based mental health services to reduce family violence and harsh parenting practices, and for effective use of mHealth strategies to improve healthcare delivery and quality. This study will leverage Government of Sierra Leone investments in community health initiatives and mHealth innovations as a strategy to address critical healthcare workforce limitations that plague delivery of evidence-based interventions to vulnerable families in post-conflict Sierra Leone. The study will pilot mHealth-supported delivery of a culturally adapted version of the Family Strengthening Intervention for Early Childhood Development (FSI-ECD). The FSI-ECD has demonstrated effectiveness in improving parental emotion regulation and reducing family violence and harsh parenting practices among high-risk families with children aged 6-36 months in Rwanda. Study aims are to:

Aim 1. Employ a five-phase user-centered design approach to develop and test mHealth tools to improve training, supervision, and fidelity monitoring of Community Health Workers. Study investigators hypothesize that mHealth tools will be feasible, acceptable, and user-friendly.

Aim 2. Conduct a Randomized Controlled Pilot Study to assess feasibility, acceptability, and preliminary effects of the mHealth-supported delivery of FSI-ECD on parent mental health, emotion regulation, and familial violence in high risk families with children aged 6-36 months (n=40) in comparison to control families (n=40) who receive standard care. Parental mental health, emotion regulation, household violence, and parenting practices will be assessed at baseline, post-intervention and 6-month follow-up. The pilot study will also integrate a cost-effectiveness analysis to assess the economic value of the mHealth-supported delivery of the FSI-ECD vs. standard care. Study investigators hypothesize that (a) the effects of the FSI-ECD will be comparable to results observed with vulnerable families in Rwanda; (b) digital tools will be feasible and acceptable to CHWs and supervisors; and (c) mHealth-enhanced supervision and fidelity monitoring will increase supervisor engagement and support CHW quality improvement cycles.

Aim 3. Leverage well-established relationships and government partners to strengthen capacity for mHealth research and quality healthcare delivery in Sierra Leone. Partners include the University of Makeni, the Directorate of Science, Technology and Innovation, and the Ministry of Health and Sanitation.


Improving Family Engagement in Coordinated Specialty Care for First Episode Psychosis

Study Type: Interventional
Start Date: January 1, 2021
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): New Journeys: Coordinated specialty care, Yakima, Washington, United States

Investigators aim to develop and evaluate a culturally informed family motivational engagement strategy (FAMES) and implementation toolkit for coordinated specialty care (CSC) programs for first episode psychosis. First, 5 family member participants will be recruited into a three-month trial of FAMES and implementation toolkit. The investigators will then conduct a 16-month non-randomized, stepped-wedge trial with 50 family members from 5 CSC programs in community-based mental health clinics.


Perceptual Abnormalities and Their Malleability in BDD

Study Type: Interventional
Start Date: December 1, 2020
Eligibility: 18 Years to 40 Years, Accepts Healthy Volunteers
Location(s): Centre for Addiction and Mental Health, Toronto, Ontario, Canada

A core symptom of body dysmorphic disorder (BDD) is perceptual distortions for appearance, which contributes to poor insight and delusionality, limits engagement in treatment, and puts individuals at risk for relapse. Results from this study will provide a comprehensive mechanistic model of brain, behavioral, and emotional contributors to abnormal perceptual processing, as well as how malleable it is with visual modulation techniques. This will lay the groundwork for next-step translational perceptual retraining approaches.


Artificial Intelligence to Measure Adherence to Oral Medication

Study Type: Interventional
Start Date: November 20, 2020
Eligibility: 15 Years to 40 Years, Does Not Accept Healthy Volunteers
Location(s): InterAct of Michigan, Kalamazoo, Michigan, United States; InterAct, Grand Rapids, Michigan, United States

The aims of this project is to use an artificial intelligence (AI) smartphone app to provide support for medication adherence by patients with first episode psychosis.


Non-Invasive Brain Stimulation to Control Large-Scale Brain Networks

Study Type: Interventional
Start Date: November 1, 2020
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): University of Minnesota, Minneapolis, Minnesota, United States

This project will assess the feasibility of traveling wave transcranial alternating current stimulation (tACS) to modify working memory performance and large-scale brain connectivity in surgical epilepsy patients.


Measurement Training and Feedback System: Family Therapy and CBT

Study Type: Interventional
Start Date: September 1, 2020
Eligibility: Age N/A, Does Not Accept Healthy Volunteers
Location(s): Montefiore, New York, New York, United States; The LGBT Community Center, New York, New York, United States; Roberto Clemente Center, New York, New York, United States

This study aims to advance the science of mental health services for adolescent externalizing problems (AEPs) by developing therapist training procedures to increase fidelity to evidence-based interventions (EBIs) in usual care. Two widely endorsed approaches are consistently effective for treating AEPs: family therapy and CBT. Importantly, stronger fidelity to core EBIs of these approaches predicts better outcomes in research and community settings. Yet these EBIs are not widely implemented with fidelity. To help close this quality gap in adolescent services, investigators will develop an online intervention to strengthen fidelity to these EBIs in routine care: Measurement Training and Feedback System for implementation (MTFS-I). MTFS-I will target two essential aspects of EBI fidelity: Training components will seek to improve EBI self-monitoring, and a Feedback component will seek to increase EBI utilization. In keeping with NIMH's Experimental Therapeutics paradigm, this study will examine whether an Intervention (MTFS-I) has direct impact on immediate Targets (EBI self-monitoring and utilization).

If promising, future R01 studies will examine links among intervention, targets, and ultimate outcomes (AEPs). The MTFS-I package will be an online quality assurance system completed by therapists and supervisors that can be readily sustained in usual care. Two weekly Training components will adapt gold-standard observational fidelity coding procedures to promote improved self-monitoring of the targeted EBIs, and a monthly Feedback component will adapt a measurement feedback system to promote increased utilization of these EBIs in everyday practice. To maximize provider investment, sites will delineate their own fidelity standards for family therapy and CBT and help design feedback report templates.

The proposed study will be among the first to (1) test whether training therapists in observational assessment of EBI fidelity increases the accuracy with which they self-monitor use of those EBIs and (2) adapt measurement feedback procedures to track and improve therapist utilization of EBIs. To achieve study aims the investigators will first partner with two community clinics to develop sustainable MTFS-I procedures using a three-phase Pilot process. Investigators will then initiate an experimental Trial during which therapists (n = 32, treating 192 clients) at four different clinics will be randomized to MTFS-I versus no-intervention Control. In both conditions two kinds of data will be collected: therapist-report checklists on use of core family therapy and CBT techniques with adolescent cases and treatment session audio recordings. MTFS-I uptake will be tracked electronically for online components (Aim 1: MTFS feasibility). Session recordings will be coded by observers for three facets of EBI fidelity: adherence (extent of EBI utilization), working alliance, and therapist competence. Observer ratings will measure the strength of EBI self-monitoring (Aim 2: therapist reliability and accuracy) and fidelity (Aim 3 [EBI utilization] & Aim 4 [alliance, competence]). If effective, MTFS-I could be adapted to promote EBI fidelity for a variety of clinical populations and approaches.


Facilitating Engagement in Evidence-Based Treatment for Early Psychosis

Study Type: Interventional
Start Date: September 1, 2020
Eligibility: 18 Years to 30 Years, Does Not Accept Healthy Volunteers
Location(s): CMSU Behavioral Health & Developmental Services, Danville, Pennsylvania, United States

The purpose of this mixed methods study is to evaluate a peer-delivered decision support intervention with emerging adults newly enrolled in an early intervention program, also known as coordinated specialty care (CSC). It is hypothesized that participants will experience a reduction in decision-making needs after participating in the intervention, and that study and intervention procedures will demonstrate feasibility and acceptability.


Foster Care Mental Health Family Navigator

Study Type: Interventional
Start Date: August 20, 2020
Eligibility: 12 Years to 17 Years, Does Not Accept Healthy Volunteers
Location(s): UCSF Zuckerberg San Francisco General Hospital, San Francisco, California, United States

This study will focus on developing and testing a family-based mental health navigator intervention, the Foster Care Family Navigator (FCFN), to evaluate whether the intervention combined with mHealth would be efficacious in improving mental health service initiation and engagement for child welfare-involved youth.


Disengagement in CSC: Identifying Those at Risk and Addressing Their Needs

Study Type: Interventional
Start Date: July 1, 2020
Eligibility: 15 Years to 40 Years, Accepts Healthy Volunteers
Location(s): InterAct of Michigan, Grand Rapids, Michigan, United States; InterAct of Michigan, Kalamazoo, Michigan, United States; Henderson Behavioral Health, Lauderdale Lakes, Florida, United States

Maintaining treatment engagement is critical for first episode psychosis patients to experience gains possible with coordinated specialty care (CSC). This study is designed to identify CSC participants still receiving care but at high risk for disengagement and to intervene to prevent/delay disengagement.


Neural Biomarkers of Electroconvulsive Therapy Response

Study Type: Interventional
Start Date: April 1, 2020
Eligibility: 18 Years to 80 Years, Does Not Accept Healthy Volunteers
Location(s): The Zucker Hillside Hospital, Glen Oaks, New York, United States

In the proposed study, we will utilize resting-state functional MRI (fMRI) and structural MRI-based electrical field modeling to study the effect of electroconvulsive therapy on human neural circuitry. Our study will recruit patients who are beginning treatment with bilateral electroconvulsive therapy (N=75). Our design will be longitudinal we will follow patients up until their 8th week electroconvulsive therapy clinically. The primary measure of interest will be the slope of clinical change estimated with mixed effect modeling (see Approach). Secondary measures will be the cognitive performance change between baseline and the 8th week electroconvulsive therapy time point.


Navigation and Parent Peer Support to Promote Access

Study Type: Interventional
Start Date: February 18, 2020
Eligibility: 5 Years to 99 Years, Accepts Healthy Volunteers
Location(s): Uplift Wyoming, Cheyenne, Wyoming, United States; University of Colorado School of Medicine, Aurora, Colorado, United States; Allegheny Family Network, Pittsburgh, Pennsylvania, United States

Nearly one in five children in the United States has a mental health problem that interferes with daily functioning and requires intervention, and yet less than 50% of children who need mental health care receive any services. Families and especially from low-income and ethnically diverse backgrounds, experience a range of barriers to engaging in services for their children including: lack of recognition of problems and knowledge of available treatments, connecting to services, trust in providers, stigma; low income and ethnically diverse populations are especially affected by these barriers. In this work, the investigators propose to carry out initial testing of a research- and theory-based model of Parent Peer Navigation services to help engage families with children with significant but pre-clinical problems in mental health services in order to prevent future poorer outcomes for children, who otherwise may never receive services, or only receive services when their mental health issues become severely debilitating for themselves and their family.


Morning Light Treatment for Traumatic Stress: The Role of Amygdala Reactivity

Study Type: Interventional
Start Date: January 24, 2020
Eligibility: 18 Years to 60 Years, Does Not Accept Healthy Volunteers
Location(s): The University of Michigan, Ann Arbor, Michigan, United States

The purpose of this study is to determine the effect of different amounts of time of morning light on brain emotional processing.


Feasibility of an Early Detection Program for Early Psychosis on a College Campus

Study Type: Interventional
Start Date: October 1, 2019
Eligibility: 15 Years to 30 Years, Accepts Healthy Volunteers
Location(s): University of New Mexico, Albuquerque, New Mexico, United States

The objective of the proposed study is to determine the feasibility of an Early Detection program that aims to: (i) identify college students at clinical high risk (CHR) of psychosis or with first episode psychosis (FEP), and (ii) efficiently link them to coordinated specialty care (CSC) services for a 2nd stage screen, a clinical assessment, and appropriate treatment. Preliminary estimates of effectiveness with respect to the intervention will also be provided.


The Implementation and Sustainment of Digital MBC in Youth Mental Health Services

Study Type: Interventional
Start Date: October 1, 2019
Eligibility: 4 Years and Older, Accepts Healthy Volunteers
Location(s): Boise State University, Boise, Idaho, United States

This study will investigate the effects of an intervention called Leadership and Organizational Change for Implementation (LOCI), relative to implementation as usual (IAU), on clinician fidelity to, and youth service outcomes of, a well-established digital measurement-based care intervention called the Outcomes Questionnaire-Analyst in outpatient community mental health clinics.


OnTrackNY's Learning Healthcare System

Study Type: Observational
Start Date: August 15, 2019
Eligibility: 16 Years and Older
Location(s): OnTrackNY Central, New York, New York, United States

This application proposes OnTrackNY as a regional scientific hub for the Early Psychosis Intervention Network (EPINET) program as part of the National Institute of Mental Health (NIMH)'s creation of a national learning health care system (LHS) for early psychosis care. OnTrackNY has grown into a 22-site network, under the leadership of Lisa Dixon, MD, MPH.

Created and supported by the New York State's Office of Mental Health (OMH), OnTrackNY is a nationally recognized model providing coordinated specialty care (CSC) for adolescents and young adults within two years of the onset of non-affective psychosis. OMH regulates and licenses all mental health programs in New York and is a direct-services provider via state-operated programs statewide. This makes OMH an ideal partner for establishing a statewide learning health care system for early psychosis care. Further, OnTrackNY's administration, OnTrackCentral, operates within the OMH-supported Center for Practice Innovations at Columbia Psychiatry. In this model, OnTrackCentral serves as the hub and the 22 OnTrackNY programs serve as the spokes. Since 2014, the still-growing OnTrackNY network has served over 1,600 individuals. From its inception, OnTrackNY has aimed to deliver high-quality, data-driven, accountable and culturally competent care consistent with an LHS. As a condition of funding, all OnTrackNY providers follow established protocols that require submission of patient- and site-level standard measures of early psychosis clinical features, services, and treatment outcomes.

The proposed EPINET regional hub, the OnTrackNY LHS, will emphasize and enhance two critical foundational components - Aim 1: proactively engage stakeholders to optimize understanding of key problems and their solutions at every LHS phase; and Aim 2: develop data systems with enhanced standardized data collection, including post-discharge data and linkages to external data systems, and enhancing data analytics that will allow for client-level treatment planning and prospective analytics, delivering real time, dynamic and actionable information to stakeholders. These LHS components do not follow in a stepwise sequence but instead operate in parallel and interact to facilitate and enhance quality improvement processes. This backbone will support the development of practice-based research.


Analysis of Electrocorticographic Signals

Study Type: Interventional
Start Date: July 19, 2019
Eligibility: 18 Years to 65 Years, Does Not Accept Healthy Volunteers
Location(s): University of Wisconsin, Madison, Wisconsin, United States

The objectives of this research are to understand how the brain can keep information in mind ("working memory"), and use this information to guide behavior. The two experiments that fall under this study will collect brain signals from epilepsy patients who are having surgery as part of their treatment. More specifically, these signals will be studied from the time while the patient is performing two cognitive tasks.The endpoints are publication of the results from each of the proposed experiments in peer-reviewed journals.


Family Partner Navigation for Children

Study Type: Interventional
Start Date: June 24, 2019
Eligibility: 3 Years to 12 Years, Does Not Accept Healthy Volunteers
Location(s): DotHouse Health, Dorchester, Massachusetts, United States

Family Navigation (FN), an evidence-based care management strategy which is a promising intervention to help low income and minority families access timely mental health services. Despite significant evidence supporting the effectiveness of FN, concerns exist about the ability to disseminate FN to a broad population due to inefficiency and cost. The proposed study employs an innovative research methodology, the Multiphase Optimization STrategy (MOST), a framework for developing highly efficacious, efficient, scalable, and cost-effective interventions. The investigators will conduct a randomized experiment to assess the individual components of FN and identify which components and component levels have greatest effect on access to, and engagement in, diagnostic and treatment services for children with mental health disorders. This information then guides assembly of an optimized FN model that achieves the primary outcomes with least resource consumption and participant burden


Novel PET Radioligands as Inflammatory Biomarkers in Rheumatoid Arthritis and Myositis

Study Type: Interventional
Start Date: June 14, 2019
Eligibility: 18 Years and Older, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

Inflammation can play a role in diseases like heart disease and rheumatoid arthritis. PET scans can help detect inflammation. Two new drugs may create better PET images.

Objective:

To see if the drugs [11C]ER176 and [11C]MC1 can help image inflammation.

Eligibility:

People ages 18 and older with rheumatoid arthritis or idiopathic inflammatory myopathy (IIM).

Healthy volunteers enrolled in protocol 01-M-0254 or 17-M-0181 are also needed.

Design:

Healthy participants will be screened under protocol 01-M-0254 or 17-M-0181.

Participants with arthritis or IIM will have a screening visit. This will include:

Medical history

Physical exam

Blood and urine tests

Possible CT or X-ray: A machine will take pictures of the body.

Healthy participants will have 1 or 2 visits. They may have urine tests. They may take the drug celecoxib by mouth. They will have a PET scan. A small amount of one or both study drugs will be injected through a catheter: A needle will guide a thin plastic tube into an arm vein. Another catheter will draw blood. They will like on a bed that slides into a machine. Their vital signs and heart activity will be measured.

Participants with arthritis will have up to 2 visits after screening. They may take celecoxib and have PET scans.

Participants with IIM will have up to 3 visits after screening. At 1 or 2 visits, they will take celecoxib and have PET scans. They will have 1 visit where they have an MRI: They will lie on a table that slides into a machine. The machine takes pictures of the body.


Maximizing the Impact of Neuroplasticity Using Transcranial Electrical Stimulation Study 1

Study Type: Interventional
Start Date: April 1, 2019
Eligibility: 18 Years to 60 Years, Accepts Healthy Volunteers
Location(s): University of Minnesota, Minneapolis, Minnesota, United States

Non-invasive neuromodulation, such as transcranial direct current stimulation ( tDCS) , is emerging as an important therapeutic tool with documented effects on brain circuitry, yet little is understood about h ow it changes cognition. In particular, tDCS may have a critical role to play in generalization, that is how training in one domain generalizes to unlearned or unpracticed domains. This problem has resonance for disorders with cognitive deficits, such as schizophrenia.

Understanding how tDCS affects brain circuity is critical to the design and application of effective interventions, especially if the effects are different for healthy vs. psychiatric populations. In previous research, one clue to the mechanism underlying increased learning and generalization with tDCS was provided by neuroimaging data from subjects with schizophrenia undergoing cognitive training where increases in thalamocortical (prefrontal) functional connectivity (FC) predicted greater generalization.

The premise of this proposal is that increases in thalamocortical FC are associated with the generalization of cognitive training, and tDCS facilitates these increases. The overarching goals of this proposal are to deploy neuroimaging and cognitive testing to understand how tDCS with cognitive training affect thalamocortical circuitry in individuals with and without psychosis and to examine variability in response within both groups.

Study 1 will compare right prefrontal, left prefrontal and sham tDCS during concurrent cognitive training over 12 weeks in 90 healthy controls. Study 2 will be similar in all aspects but will examine 90 patients with schizophrenia or schizoaffective disorder and include clinical assessments. Results of the study will provide crucial information about location of stimulation, length of treatment, modeled dosage, trajectory and durability needed to guide future research and interventions for cognitive impairments.


Oscillatory Contributions to Working Memory and Attention

Study Type: Interventional
Start Date: March 1, 2019
Eligibility: 18 Years to 35 Years, Accepts Healthy Volunteers
Location(s): University of Wisconsin - Madison, Madison, Wisconsin, United States

The objectives are articulated in the proposal's specific aims:

Aim 1: To test the hypothesis that the cognitive control of unattended memory items (UMI) is implemented by the same frontoparietal mechanisms that control spatial and nonspatial attention.

Aim 2: To test the hypothesis that the selection of visual stimuli, whether from the environment or from WM, is accomplished, in part, by the hijacking of low-frequency oscillatory dynamics that are fundamental to the waking-state physiology of the corticothalamic circuitry of the visual system.

Aim 3: To test the hypothesis that the function of context binding contributes to delay-period activity of the posterior parietal cortex (PPC).


Stress, Sex, and Fear

Study Type: Interventional
Start Date: January 25, 2019
Eligibility: 18 Years and Older, Accepts Healthy Volunteers
Location(s): Ohio Northern University, Ada, Ohio, United States

The impact of well-known risk factors for such disorders (stress, biological sex, anxiety-related dispositions) on fear generalization will be examined. Findings from this study may provide insight into how these risk factors influence the development and/or maintenance of psychological disorders that involve overgeneralization of fear and could facilitate future approaches to their treatment.


Unobtrusive Sensing of Medication Intake ("USE-MI")

Study Type: Interventional
Start Date: January 8, 2019
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Swedish Medical Center, Seattle, Washington, United States

The purpose of this study is to test the USE-MI system hardware and software to see if it can accurately measure when subjects take their HIV-related medications and help them remember to take these medications. With the use of a smartwatch and smartphone "app", investigators hope to be able to monitor medication adherence in real-time and send subjects electronic reminders when they may have forgotten to take their medication.


Psychosis Screening in Juvenile Justice

Study Type: Interventional
Start Date: September 1, 2018
Eligibility: 12 Years to 17 Years, Does Not Accept Healthy Volunteers
Location(s): Brown Univerity, Providence, Rhode Island, United States; Rhode Island Family Court, Providence, Rhode Island, United States

This study will investigate the occurrence of psychosis-spectrum disorders among youth in the Juvenile Justice System and track mental health referrals for these youth in Phase 1, a standard care condition. Then, in Phase 2, an enhanced referral and linkage to care model will be employed, with the aim of bolstering motivation for and engagement in mental health treatment. It is hypothesized that the enhanced referral protocol will promote completion of mental health care referrals.


Behavioral and Neural Representations of Subjective Effort Cost

Study Type: Interventional
Start Date: August 1, 2018
Eligibility: 18 Years to 35 Years, Accepts Healthy Volunteers
Location(s): Kennedy Krieger Institute, Baltimore, Maryland, United States

The goal of this proposal is to understand the common and distinct behavioral and neural representations of subjective effort valuation, and how these representations are influenced by fatigue and changes in motivation. It is hypothesized that the brain will use overlapping and distinct neural circuits to represent cognitive and physical effort value, and that fatigue and enhanced motivation will influence the subjective value of effort.


Technical and Translational Development of Cardiovascular Magnetic Resonance (CMR) Imaging

Study Type: Interventional
Start Date: July 12, 2018
Eligibility: 7 Years and Older, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

Magnetic resonance imaging (MRI) is an important non-invasive tool to study and diagnose cardiovascular disease. MRI scanners use strong magnetic fields and radio waves to create pictures of body organs. Researchers want to find better MRI methods and new ways of imaging cardiovascular disease and better understand normal and abnormal cardiovascular and brain function. Researchers are also interested in seeing if gadolinium, the commonly used MRI contrast agent, stays in the body long after the MRI was performed.

Objectives:

To develop new methods for imaging the heart and other organs of the body.

To describe cardiovascular diseases using newer MRI methods

To look at the relationship between cardiovascular disease and cardiovascular risk factors and other organ systems

To look for gadolinium deposits in the brain from prior exams.

Eligibility:

Healthy people and people with known or suspected cardiovascular disease ages 7 and older may be eligible for this study.

Researchers may be particularly interested in those who:

Have suspected or known cardiovascular disease Were previously exposed to a gadolinium-based contrast agent, Need to have a heart MRI scheduled Need a test of the heart or other body part or will be undergoing a future cardiac catheterization

Design:

There are multiple arms to the study with optional components; therefore, there are multiple variations as to what an individual participant s experience may involve.

Participants will have an MRI scan lasting up to 2 hours. The scanner is a large hollow tube. During the scan, there may be loud knocking and buzzing sounds caused by the scanner. Participants will lie on a table that slides in and out of the tube. Their vital signs may be monitored.

Participants may have a test of heart electrical activity using wires connected to pads on the skin.

Participants may have blood drawn.

Participants may be injected with an MRI contrast agent through a plastic tube inserted in the arm.


Development of Non-Invasive Brain Stimulation Techniques

Study Type: Interventional
Start Date: January 11, 2018
Eligibility: 18 Years to 65 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

Noninvasive brain stimulation (NIBS) may help diagnose and treat psychiatric and neurological illness. But there is not enough research on how to apply NIBS. This includes how strong to make it, where on the brain to apply it, and for how long. Researchers also want to see what the brain is doing when it receives NIBS.

Objective:

To increase the effectiveness of NIBS.

Eligibility:

Healthy native English speakers ages 18-65

Design:

Participants will be screened under another protocol with:

Medical and psychiatric history

Psychiatric evaluation

Physical exam

Urine tests

All participants will start with a 2-hour visit for screening. (see below). They may learn how to do tasks that will be used later. After the screening session, they will be scheduled for an MRI session.

The next part of the study is 4 substudies. Each substudy includes up to 4 sessions. A session is usually 2-3 hours but can last up to 8 hours. Participants can join multiple substudies, but only 1 at a time. They can do only 1 session on a given day.

Each substudy includes the following:

Behavioral tests: Interviews; questionnaires; simple tasks; and tests of memory, attention, and thinking

Electromyography: Small sticky electrodes on the skin measure muscle activity.

Transcranial magnetic stimulation: A wire coil is held to the scalp. A brief electrical current passes through the coil and affects brain activity.

Magnetic resonance imaging (MRI): Participants lie on a table that slides into a machine that takes pictures of the brain. A coil is placed over the head. They will perform simple tasks while in the scanner. They may also get TMS.

Electroencephalography: Small electrodes on the scalp record brain waves.

Sponsoring Institution: National Institute of M


Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies

Study Type: Observational
Start Date: November 1, 2017
Eligibility: 18 Years and Older, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Objective: To screen and create a list of adult volunteers in good health for participation in research studies conducted at the National Institutes of Health (NIH) in Bethesda, Maryland. Develop a normative set of structural and functional brain MRI scans that are linked to healthy research volunteer characteristics. Maximize scientific impact of data from volunteers by broadly sharing with other researchers.

Study Population: Adult males and females in general good health who are 18 years of age and older.

Design: Adult individuals who are interested in participating in NIMH IRP clinical studies as a healthy research volunteer can directly visit or be directed to visit the study website where they will first consent electronically and then complete a set of online self-report measures. Items may include: demographic information, mental health symptoms, disability status, substance use patterns, handedness and clinical/family history. Individuals who are flagged based on predetermined responses to survey items will be further screened by a member of the study clinical team. If found to be ineligible for the study because of a clinically significant or unstable medical or mental health condition, these individuals will be referred back to the community and/or given information about NIMH clinical studies for which they may be eligible. Respondents with no flags or who pass through additional screening will be scheduled for an in-person assessment. During the outpatient appointment and after in-person informed consent, participants will receive a brief clinical interview to screen for current medical and mental conditions, and risk for self-harm. They will complete assessments of psychological, emotional, physiologic, biological and cognitive functioning. Participants will undergo a physical exam and be asked to provide blood and urine samples for routine clinical labs as well as additional blood samples for future secondary analysis that could include genetic or biomarker assays. Participants can separately consent for an optional baseline brain magnetic resonance imaging (MRI) scan and an optional magnetoencephalography (MEG) exam. All consent forms will explicitly inform participants that if enrolled in the study, their de-identified data will be broadly and publicly shared through NIH-approved data repositories. Participants in this recruitment and characterization study will then be placed on a list of healthy research volunteers from which other NIMH IRP studies may recruit according to the inclusion and exclusion criteria in their respective IRB-approved protocols.

Outcome Measures: Outcome measures may include demographic data, mental and medical history and symptoms, results of psychological, emotional, physiologic, biological, and cognitive testing, physical exam and MRI findings.

...


Evaluation of a Novel PET Radioligand to Image Cyclooxygenase-1 (COX-1)

Study Type: Observational
Start Date: October 3, 2017
Eligibility: 18 Years to 99 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

A radioligand is a radioactive substance that is used to diagnose diseases. A new ligand is called [11C]PS13. This has a small amount of radioactivity that can be detected by a positron emission tomography (PET) scan. If this ligand works well in this study, researchers may be able to use it to better understand and diagnose brain disorders.

Objectives:

To evaluate if [11C]PS13 can measure its receptor, which is involved in inflammation. To see if researchers get the same results when scanning a person twice.

Eligibility:

Healthy people ages 18 and older who are in Protocol 01-M-0254.

Design:

This study requires three visits of 2-5 hours each.

Participants will have 2 PET scans with [11C]PS13.

A needle will guide a small plastic tube (catheter) into an arm vein. The needle will be removed, leaving only the catheter in the vein. The ligand will be injected through the catheter.

The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner.

Participants will wear a molded a plastic mask that fits the head.

Another catheter will be put into an artery at the wrist or elbow area.

Vital signs will be monitored during the PET scan. Participants will have a test during the PET scan to monitor heart function.

Participants will have blood and urine tests.

Participants will have 1 magnetic resonance imaging (MRI) scan. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder.


NIAID Centralized Sequencing Protocol

Study Type: Observational
Start Date: July 31, 2017
Eligibility: Age N/A, Accepts Healthy Volunteers
Location(s): Children's National Health System, Washington, District of Columbia, United States; National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

Genetic testing called "sequencing" helps researchers look at DNA. Genes are made of DNA and are the instructions for our bodies to function. We all have thousands of genes. DNA variants are differences in genes between two people. We all have lots of variants. Most are harmless and some cause differences like blue or brown eyes. A few variants can cause health problems.

Objective:

To understand the genetics of immune disorders various health conditions, as well as outcomes of clinical genomics and genetic counseling services performed under this protocol.

Eligibility:

Participants in other NIH human subjects research protocols - either at the NIH Clinical Center (CC) or at Children s National Health System (CNHS) - (aged 0-99 years), and, in select cases, their biological relatives

Design:

Researchers will study participant s DNA extracted from blood, saliva, or another tissue sample, including previously collected samples we may have stored at the NIH. Researchers will look at participant s DNA in great detail. We are looking for differences in the DNA sequence or structure between participants and other people.

Participants will receive results that:

Are important to their health Have been confirmed in a clinical lab Suggest that they could be at risk for serious disease that may affect your current or future medical management.

Some genetic information we return to participants may be of uncertain importance.

If genetic test results are unrelated to the participant s NIH evaluations, then we will not typically report:

Normal variants Information about progressive, fatal conditions that have no effective treatment Carrier status (conditions you don t have but could pass on)

The samples and data will be saved for future research.

Personal data will be kept as private as possible.

If future studies need new information, participants may be contacted.


Hand Rehabilitation Study for Stroke Patients

Study Type: Interventional
Start Date: April 4, 2017
Eligibility: 18 Years to 80 Years, Does Not Accept Healthy Volunteers
Location(s): University of California, San Francisco, San Francisco, California, United States

The purpose of this study is to find out what are the best settings for applying electrical nerve stimulation over the skin for the short-term improvement of hand dysfunction after a stroke. The ultimate goal is to some day design an effective long-term training program to help someone recovery their ability to use their hands and function independently at home and in society. In order to know how to apply electrical nerve stimulation to produce a good long-term effect on hand dysfunction, we first need to know how to make it work best in the short-term, and improve our understanding of for whom it works and how it works.We will use a commercially available transcutaneous electrical nerve stimulation (TENS) unit to gently apply electrical nerve stimulation over the skin of the affected arm. This is a portable, safe and easy to use device designed for patients to operate in their homes.


Innovative Methods to Assess Psychotherapy Practices (imAPP)

Study Type: Observational
Start Date: April 1, 2017
Eligibility: 18 Years and Older, Accepts Healthy Volunteers
Location(s): VA Palo Alto Health Care System, Palo Alto, California, United States; Massachusetts General Hospital, Chelsea, Massachusetts, United States; Aaron T. Beck Psychopathology Research Center, Philadelphia, Pennsylvania, United States; NCPTSD - VA Boston HCS, Boston, Massachusetts, United States

This project compares two methods of assessing the quality of cognitive behavioral therapy (CBT) that do not involve directly observing sessions: 1) adherence checklists embedded in clinical notes, and 2) rating the quality of worksheets that are completed with therapist guidance during sessions. It also examines whether ratings of worksheets completed on a mobile app are reliable and valid quality measures. This information can inform strategies to monitor and enhance CBT quality, which can ultimately improve the quality of care and clinical outcomes.


Influence on Plasticity of Brain Temperature

Study Type: Interventional
Start Date: May 3, 2016
Eligibility: 18 Years to 50 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Background:

- Brain activity changes with changes in body temperature. Brain activity can be studied with a procedure called transcranial magnetic stimulation (TMS). Researchers want to cool the brain through the scalp using a cooling cap. They want to see if cooling changes the brain and body s response to TMS.

Objectives:

- To look at the effects of cooling on the brain.

Eligibility:

- Right-handed adults age 18-50 who can abstain from caffeine and tobacco.

Design:

Participants will be screened with medical history and physical exam. They will be asked about alcohol use, smoking, and substance abuse. They may take a pregnancy test. They may have a magnetic resonance imaging (MRI) scan of the brain. For MRI, participants lie on a table that slides in and out of a metal tube that takes pictures. Participants will have 3 outpatient visits. The following procedures will occur at each visit. Participants will wear a cooling cap for up to 45 minutes. Cool water will flow through the cap. It will feel like an ice pack in a towel. Their core temperature will be monitored. Their temperature will also be measured under their tongue and on scalp, stomach, forearm, and calf. Participants will have TMS before and after wearing the cap. A brief electrical current will pass through a wire coil held on their scalp. Electrodes that detect muscle movement will be placed on their hand. They will also have repetitive TMS, which uses repeated magnetic pulses. Their wrist will also receive a shock.


Psychological Treatments for Youth With Severe Irritability.

Study Type: Observational
Start Date: November 17, 2015
Eligibility: 8 Years to 17 Years, Does Not Accept Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

When children have severe irritability and temper outbursts, they can be so cranky or angry that it leads to problems at home, in school, and with friends. This is called Disruptive Mood Dysregulation Disorder (DMDD) and there have been no psychological treatments developed specifically for children with this problem. Researchers think two forms of therapy, Cognitive Behavioral Therapy (CBT) and Interpretation Bias Training (IBT), might help children with DMDD.

Objective:

To test two whether IBT and CBT can decrease severe irritability in children and youth.

Eligibility:

Children 8-17 years old with DMDD. Their symptoms must have started before age 10.

Design:

Participants will be screened with a review of their symptoms. Parents and participants will answer questions.

Participants can do only one or both of these treatments if they wish. Those who wish to do both will start with IBT.

Participants who do CBT will have 12-16 weekly meetings of research talk therapy. A parent will participate in part of the sessions.

Participants will talk about what makes them irritable and how it affects them. They may be put in situations that might make them annoyed or irritable.

Participants will rate how intense their irritability is. Parents and participants will complete rating scales, questionnaires, and interviews.

Participants will do practice activities at home.

Participants doing IBT will have up to 14 sessions over 10 weeks.

Participants will view 15 faces, one at a time, on a computer. They will choose if the face looks happy or angry on a computer. Sometimes the computer gives feedback. Participants will complete some sessions at the NIH and some at home.

Participants and parents answer questions about their progress.


Checking Out Checking In: The Development and Validation of an Electronic Screening Tool for Pediatric Psychosocial Distress

Study Type: Observational
Start Date: April 14, 2015
Eligibility: 8 Years to 21 Years, Does Not Accept Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States; Carolinas Medical Center, Charlotte, North Carolina, United States; Johns Hopkins University, Baltimore, Maryland, United States; Children s Hospital Colorado, Aurora, Colorado, United States

Background:

- Medical problems and treatments can cause stress in some people. Researchers want to learn more about how to measure distress in young people with medical illnesses. A screening tool called Checking In will be developed in order to help researchers find ways to identify concerns and stresses common to this group.

Objective:

- To create a screening tool that will help health care providers identify psychological and social distress in young people with serious illnesses.

Eligibility:

- Outpatient youth ages 8 21 who are enrolled on a research protocol at the NIH at the time of the study.

Design:

Phase 1 participants will complete a paper-and-pencil version of Checking In. It asks about mood, pain, fatigue, peer relationships, and sleep. During this phase, participants will be asked about the wording of the questions in Checking In. They will also talk about what they thought of the questions and if they understood them. Phase 2 will not involve participant enrollment. During this phase the researchers will be working with technologists to develop the software for an electronic version of Checking In. Phase 3 participants will complete an electronic version of Checking In. Researchers will ask questions about the ease or difficulty of using an electronic screen. Phase 4 participants and one of their caregivers will complete an electronic version of Checking In. They will also complete other questionnaires related to mood, pain fatigue, peer relationships and sleep. They will be asked their thoughts about using Checking In. On the same day, their NIH doctor will get summary data about their questionnaire answers. The doctor will also provide feedback about the summary form. Researchers will compare data from Checking In with data from the other questionnaires.


Exercise and Markers of Medial Temporal Health in Youth At-risk for Psychosis

Study Type: Interventional
Start Date: July 31, 2014
Eligibility: 16 Years to 24 Years, Accepts Healthy Volunteers
Location(s): ADAPT Program, Boulder, Colorado, United States

The goal of this proposal is to test the feasibility and effectiveness of cardiovascular exercise in promoting brain health and improving related symptoms (e.g., hearing sounds that are not there, feeling emotionally detached from self and others), cognitive difficulties (troubles with memory and learning), and every day social-occupational functioning in youth at imminent risk for developing a psychotic disorder such as schizophrenia. Understanding how exercise may protect or improve the health of a brain area that is implicated as a major contributing factor to the onset of psychosis may lead to a path-breaking new intervention that does not suffer from many of the side effects, costs, and other barriers that characterize treatments that are currently available for this group. Because a significant portion of high-risk youth go on to develop a psychotic disorder in a short period, intervening at this stage may help to improve the clinical course and ultimately prevent the onset of a devastating and prevalent mental illness.


Brain Stimulation and Vision Testing

Study Type: Observational
Start Date: March 4, 2013
Eligibility: 18 Years to 50 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Background:

-The brain has two systems for recognizing objects. One system recognizes what an object is, and the other system recognizes where the object is located. However, there is much about how the brain handles and interprets the information from these two systems that is still unclear. Researchers want to study the parts of the brain that are involved in how vision is processed. They will use magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS) or transcranial electrical stimulation (tES) on the brain. MRI measures what parts of the brain become more active when tasks are performed. TMS uses magnetic pulses to temporarily change the activity in parts of the brain. tES uses electrical current to temporarily change brain function.

Objectives:

-To better understand how people visually recognize different types of objects.

Eligibility:

-Healthy volunteers between 18 and 50 years of age.

Design:

This study includes many different experiments on vision. Each experiment may combine visual tasks, MRI scans, and TMS or tES. Participants may be asked to have several different tests. Each test will require a separate visit to the National Institutes of Health. Participants will be screened with a physical exam and medical history. They will have a baseline brain scan at the first visit. Participants may do visual tasks alone, with MRI only, with TMS or tES only, or with MRI and TMS or tES combined. For the visual tasks, they will look at pictures of objects on a computer screen. Sometimes the images will appear very briefly (less than one-tenth of a second). Sometimes they will appear for up to 5 seconds. These images will be of things like faces, bodies, tools, and scenes. Participants will be asked to respond in different ways to the pictures. They may respond by typing on a computer keyboard or by pressing a button. Participants will have time to practice the tasks before the experiment. Participants will remain on the study for up to 3 years.


Top-Down Attentional Control of Visual-Processing

Study Type: Observational
Start Date: July 23, 2012
Eligibility: 18 Years and Older, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Background:

- Previous studies have shown that people with certain types of brain damage may have particular problems paying attention and processing things that they see. Researchers are interested in comparing how people with brain damage and without brain damage process visual images.

Objectives:

- To better understand the areas of the brain involved in paying attention to things that are seen.

Eligibility:

- Individuals at least 18 years of age who either have had damage to one or both sides of specific parts of the brain (e.g., stroke, injury, certain neurosurgery procedures) or are healthy volunteers.

Design:

The study involves 4 to 10 visits to the NIH Clinical Center over 1 to 2 years. Each visit will last approximately 2 hours. Participants will be screened with a medical history and physical examination, and may have the cognitive testing described below during the same visit. On the first visit and for at least one visit thereafter, participants will have cognitive testing to evaluate thinking and memory. These tests will be either written tests or computer-based tests. Some participants will qualify for functional magnetic resonance imaging (fMRI) as part of the study. This part will involve a decision-making task that will be performed on a computer during the fMRI scan. Additional scans may be required as directed by the study doctors. Some randomly selected participants will be asked to have magnetoencephalography (MEG), a procedure to record very small magnetic field changes produced by brain activity. During the behavioral training, or fMRI or MEG scanning, participants may be monitored with equipment to track eye movements.


A Longitudinal Investigation of the Endocrine and Neurobiologic Events Accompanying Puberty

Study Type: Observational
Start Date: March 16, 2011
Eligibility: 7 Years to 35 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Despite the clear importance of adolescence in the emergence of a number of disease states and processes, there is surprisingly little known about how the endocrine and metabolic events accompanying puberty in humans impact normal developmental neurobiology. Epidemiologic studies have identified sexual dimorphisms in the prevalence of several neuropsychiatric disorders, including depression, schizophrenia, and substance abuse. Many of these sex differences emerge during or shortly after puberty and are maintained until the 5th-6th decade of life. For example, the two-fold greater risk of unipolar depression in women compared with men does not appear until adolescence, and prior to puberty girls are not at increased risk relative to boys. Puberty is a structured, transitional process that can be influenced by both nutritional factors and environmental stressors; nonetheless, the variability in the timing and duration of puberty is largely determined by oligogenic inheritance. Basic neuroscience research has demonstrated that hormonal events accompanying puberty impact on many of the physiologic systems involved in the regulation of brain function (e.g., the appearance of new neurons in a brain-region specific pattern, neuronal remodeling, and the pruning of cortical connectivity). Additionally, not only does stress during puberty increase the risk of disturbances in affective adaptation during adulthood, but the events accompanying puberty modify stress responsivity (e.g., alterations in the duration and peak response of hypothalamic-pituitary-adrenal [HPA] axis hormones to stressors). Moreover, animal work has demonstrated that neural connectivity differs in a brain regional specific manner according to the stage of puberty (i.e., early versus late). In humans, puberty also occurs in stages, and although the endocrinology of puberty, surprisingly, has not been fully characterized with longitudinal data, studies have documented that the physical changes measured by Tanner stages I to V are accompanied by progressive increases in the secretions of both gonadal and adrenal steroids. Nonetheless, there remains considerable variability in the timing and duration of this otherwise highly structured reproductive transition.

We propose to perform a longitudinal, naturalistic study examining changes in brain structure and function, behavior, and stress responsivity in boys and girls across the pubertal transition. Because the pubertal transition is defined by a complex series of physiologic events that emerge sequentially over several years and involve changes in multiple endocrine and growth systems, and because there is also considerable variability in the timing of these events reflecting the influence of both genetic and environmental factors, puberty cannot by delineated by age of the participants as has been done in most imaging and other neurobiological studies of adolescence. The present study will formally bridge this gap by defining pubertal events per se in participants.

Participants will include healthy boys and girls whose pubertal status will be assessed, and in whom endocrine, metabolic, and brain imaging measures will be evaluated at eight - ten month intervals from age eight years (pre-puberty) until age 17 years (post-puberty). Reproductive endocrine, metabolic, and physical measures will be employed to characterize the stage and duration of pubertal development. Outcome measures will be derived via multimodal neuroimaging techniques, cognitive/behavioral assessments, metabolic measurements, and evaluations of HPA axis function. Additionally, the impact of genetic variation on the developmental trajectory of these parameters (both reproductive and CNS) will be determined.

This cross-institute proposal will employ a multidisciplinary approach to evaluating the effects on CNS function of the process of puberty in both boys and girls. This work will not only serve to inform research on the mechanisms by which sexual dimorphisms in neuropsychiatric disorders develop, it will also have important implications for the prevention and treatment of these disorders.


Development of Magnetic Resonance Spectroscopic Imaging Techniques for Imaging Metabolites in Human Brain and Muscle

Study Type: Interventional
Start Date: January 27, 2011
Eligibility: 18 Years to 65 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Background:

- Magnetic resonance imaging (MRI) is a widely used scanning technique to obtain images of the human body and evaluate activity in the brain. A particular MRI method called magnetic resonance spectroscopy (MRS) can be used to study brain chemistry as well, which may help researchers who are studying new treatments for psychiatric illnesses. Researchers are interested in improving current MRI and MRS techniques, as well as developing new MRI and MRS techniques to view and measure brain chemicals and brain activity.

Objectives:

- To implement, develop, and optimize brain chemistry imaging techniques using magnetic resonance imaging and magnetic resonance spectroscopy.

Eligibility:

- Healthy individuals between 18 and 65 years of age.

Design:

This study will involve a screening visit and a scanning visit at the National Institutes of Health Clinical Center. Participants will be screened with a full medical and physical examination, blood and urine tests, and neurological testing. During the second visit, participants will have an MRI scan of the brain. (Participants who have received an MRI within the past year will not need to have a second one; the images of the previous scan will be used for this study.) All participants will then have an MRS scan using the same scanning equipment.


Defining the Brain Phenotype of Children With Williams Syndrome

Study Type: Observational
Start Date: January 23, 2011
Eligibility: 5 Years and Older, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

- Little is known about how the brain changes during childhood and adolescence, how genes affect this process, or how the brains of people with Williams syndrome change during this period. Genetic features of Williams syndrome affect the brain s development, but the details of this process have not been studied over time. Researchers are interested in using magnetic resonance imaging to study how the brain changes in healthy children and children with Williams syndrome and related genetic disorders.

Objectives:

- To study developmental changes in the brains of healthy children and children who have been diagnosed with Williams syndrome or a related genetic disorder.

Eligibility:

Healthy children and adolescents between 5 and 17 years of age. Children and adolescents between 5 and 17 years of age who have been diagnosed with Williams syndrome or genetic characteristics that overlap with Williams syndrome.

Design:

Participants will have a brief physical examination and tests of memory, attention, concentration, and thinking. Parents will be asked about their child s personality, behavior characteristics, and social interaction and communication skills. Both participants and their parents may be asked to complete additional questionnaires or take various tests as required for the study. Participants will have approximately 10 hours of magnetic resonance imaging (MRI) scanning, usually over 4 to 5 days, within a one month period. Some of these tests will require the participants to do specific tasks while inside the MRI scanner. Participants will be asked to return to the National Institutes of Health clinical center to repeat these procedures every 2 years thereafter until age 18.


Surveillance Monitoring for ART Toxicities Study in HIV Uninfected Children Born to HIV Infected Women

Study Type: Observational
Start Date: March 31, 2007
Eligibility: Age N/A, Accepts Healthy Volunteers
Location(s): University of Alabama, Birmingham, Alabama, United States; University of California San Diego, La Jolla, California, United States; University of Southern California, Los Angeles, California, United States; University of Colorado Denver Health Sciences Center, Aurora, Colorado, United States; Children's Diagnostic & Treatment Center, Fort Lauderdale, Florida, United States; University of Florida Health Science Center, Jacksonville, Florida, United States; University of Miami, Miami, Florida, United States; University of Illinois, Chicago, Chicago, Illinois, United States; Ann and Robert H. Lurie Children's Hospital, Chicago, Illinois, United States; Tulane University Health Sciences Center, New Orleans, Louisiana, United States; Rutgers - New Jersey Medical School, Newark, New Jersey, United States; Bronx Lebanon Hospital Center, Bronx, New York, United States; SUNY Downstate Medical Center, Brooklyn, New York, United States; New York University School of Medicine, New York, New York, United States; St. Jude Children's Research Hospital, Memphis, Tennessee, United States; Baylor College of Medicine, Houston, Texas, United States; University of Puerto Rico Medical Center, San Juan, Puerto Rico; San Juan Research Hospital, San Juan, Puerto Rico

SMARTT will estimate the incidence of conditions and diagnoses potentially related to in utero exposure to antiretroviral therapy and/or exposure in the first two months of life among children born of HIV-infected mothers.


MRS Measurement of Glutamate and GABA Metabolism in Brain

Study Type: Interventional
Start Date: September 6, 2006
Eligibility: 18 Years to 65 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

This study will use magnetic resonance spectroscopy (MRS) to measure in the brain the transfer of [13]C as it is naturally metabolized from glucose to specific chemical transmitters. From this method, we can measure the rate of production of an important excitatory neurotransmitter (glutamate) as well as an inhibitory neurotransmitter (GABA).


Effects of Arousal and Stress in Anxiety

Study Type: Interventional
Start Date: January 10, 2001
Eligibility: 18 Years to 50 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

This study has several parts. One part will examine the influence of factors such as personality and past experience on reactions to unpleasant stimuli. Others will examine the effect of personality and emotional and attentional states on learning and memory.

When confronted with fearful or unpleasant events, people can develop fear of specific cues that were associated with these events as well as to the environmental context in which the events occurred via a process called classical conditioning. Classical conditioning has been used to model anxiety disorders, but the relationship between stress and anxiety and conditioned responses remains unclear. This study will examine the relationship between cued conditioning and context conditioning . This study will also explore the acquisition and retention of different types of motor, emotional, and cognitive associative processes during various tasks that range from mildly arousing to stressful.


Studies of Blood Flow to the Brain During Thought

Study Type: Observational
Start Date: September 17, 1993
Eligibility: 18 Years to 65 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

The purpose of this study is to use brain imaging technology to measure changes in blood flow to areas in the brain as individuals perform intellectual tasks.

This study will use functional magnetic resonance imaging (fMRI) to examine blood flow to areas of the brain as participants engage in tasks associated with visual perception, visual recognition, and memory.