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Featured Studies

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


The Impact of Reactivation During Sleep on the Consolidation of Abstract Information in Humans

Study Type: Interventional
Start Date: March 29, 2023
Eligibility: 18 Years to 35 Years, Accepts Healthy Volunteers
Location(s): University of Pennsylvania, Philadelphia, Pennsylvania, United States

In any given cognitive domain, representations of individual elements are not independent but are organized by means of structured relations. Representations of this underlying structure are powerful, allowing generalization and inference in novel environments. In the semantic domain, structure captures associations between different semantic features or concepts (e.g., green, wings, can fly) and is known to influence the development and deterioration of semantic knowledge. The investigators recently found that humans more easily learn novel categories that contain clusters of reliably co-occurring features, revealing an influence of structure on novel category formation. However, a critical unknown is whether learned representations of structure are closely tied to category-specific elements, or whether such representations become abstract to some extent, transformed away from the experienced features. Further, if abstract structural representations do emerge, prior work provides intriguing hints that these representations may require offline consolidation during awake rest or sleep. The investigators have developed a paradigm in which carefully designed graph structures govern the pattern of feature co-occurrences within individual categories. Here the investigators implement a "structure transfer" extension of this paradigm in order to determine whether learning one structured category facilitates learning of a second identically structured category defined by a new set of features. This facilitation would provide evidence that structure representations are abstract to some degree. Aim 1 will use these methods to evaluate whether abstract structural representations emerge immediately during learning. Aim 2 will determine whether these representations persist, or emerge, over a delay, and whether sleep-based consolidation in particular is needed. The role of replay of recent experience during sleep will be evaluated using electroencephalography (EEG) paired with closed-loop targeted memory reactivation (TMR), a technique that enables causal influence over the consolidation of recently learned information in humans. This work will inform and constrain theories of semantic learning as well as theories of structure learning and representation more broadly.


Sustainable Habits for Encouraging Even Teen Sleep

Study Type: Interventional
Start Date: October 21, 2022
Eligibility: 12 Years to 14 Years, Accepts Healthy Volunteers
Location(s): Duke Children's Primary Care North Durham, Durham, North Carolina, United States

This study will examine the feasibility, acceptability, and effectiveness of two digital sleep interventions in improving sleep regularity and psychiatric health during a critical period of adolescence.


Circadian Influence on Prolonged Exposure Therapy for PTSD

Study Type: Interventional
Start Date: July 1, 2022
Eligibility: 25 Years to 45 Years, Does Not Accept Healthy Volunteers
Location(s): VA Boston Healthcare System, Boston, Massachusetts, United States

Proposed research will examine time-of-day effects on trauma-related fear extinction using Prolonged Exposure Therapy (PE) telemedicine for Posttraumatic Stress Disorder (PTSD) in the National Center for PTSD (NCPTSD). The primary mechanistic outcome measure will be change in psychophysiological reactivity to script-driven imagery (SDI-PR) measured, in person, at pre-treatment, after 5 PE sessions (mid-treatment), and after all 10 PE sessions (post-treatment). A secondary mechanistic outcome will be session-to-session reduction in peak subjective units of distress (SUDS) ratings to imaginal exposures. The primary clinical outcome will be change in Clinican Administered PTSD Scale (CAPS-5) severity score; a secondary clinical outcome will be session-to-session reduction in self-reported PTSD symptoms using the PTSD checklist (PCL-5). Participants meeting inclusion criteria (described below) will be randomized to either PE sessions that begin from 07:00 to a time no later than 2 hours past a participant's customary rise time, or to the last treatment session of the day beginning at 16:00 or later (26 per arm). Participants will complete daily at-home imaginal-exposure homework within the same time frame as their PE sessions are scheduled, i.e., within 2 hours of awakening for morning (AM) group and between 16:00 and 2 hours before bedtime for late afternoon (PM) group.


HIV-related Insomnia and Inflammation

Study Type: Interventional
Start Date: December 2, 2021
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Indiana University Infectious Diseases Research, Indianapolis, Indiana, United States

This randomized trial will determine the effects of internet cognitive behavioral therapy on measures of systemic inflammation in HIV-positive people receiving antiretroviral therapy.


First choIce Antidepressants: General Practitioner's Treatment Approach in the Czech Republic

Study Type: Observational [Patient Registry]
Start Date: October 15, 2021
Eligibility: 18 Years and Older, Does Not Accept Healthy Volunteers
Location(s): Artemisia všeobecné lékařství, s.r.o., Brno, Czechia; MEDIGATE Care s.r.o., Hradec Králové, Czechia; AAAmbulance, s.r.o., Litoměřice, Czechia; Poliklinika Prosek, Praha, Czechia; PragMed, s.r.o., Praha, Czechia; MUDr. František Rolinek, s.r.o., Brno, Czechia

According to the local guidelines (Recommendation for General Practitioners), the first choice Anti-Depressant (AD) in Major Depressive Disorder (MDD) in primary care should be selective serotonin reuptake inhibitors (SSRI), e.g. citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, in depression with anxiety and insomnia is preferable trazodone and in severer disorders mirtazapine. Despite all these molecules have a very good antidepressant effect, there are differences in side effect scale and tolerability.

The aim of this Study is describing of real treatment practice and MDD management in primary care - aimed to evaluate effectiveness of the treatments in depression and related symptoms: insomnia, anxiety, anhedonia and sexual dysfunction.

The primary objective of the Study is to describe the diagnostic process and treatment patterns in MDD- treatment of choice (pharmacologic with details of first choice antidepressant) in the office of GP's.

The secondary objective is to evaluate efficiency of the treatments in depression and related symptoms: insomnia, anxiety, anhedonia and sexual dysfunction and to monitor the type of side effects and comedication during the 8-weeks treatment.


Neurocognition After Perturbed Sleep

Study Type: Interventional
Start Date: September 21, 2021
Eligibility: 18 Years to 60 Years, Does Not Accept Healthy Volunteers
Location(s): Icahn School of Medicine at Mount Sinai, New York, New York, United States

Individuals with schizophrenia display a wide range of neurocognitive difficulties resulting in functional impairment and disability. Extensive evidence indicates insomnia and sleep disturbances play a substantial role in degrading cognitive functioning. However, the putative impact of insomnia and sleep disturbances on neurocognition and daily functioning has not been investigated in people with schizophrenia. The goal of this study is to characterize sleep in individuals with schizophrenia and quantify its impact on neurocognition and daily functioning.


A Novel Use of a Sleep Intervention to Target the Emotion Regulation Brain Network to Treat Depression and Anxiety

Study Type: Interventional
Start Date: May 28, 2021
Eligibility: 25 Years to 60 Years, Does Not Accept Healthy Volunteers
Location(s): Stanford University, Palo Alto, California, United States

Several lines of evidence suggest that unhealthy sleep patterns contribute to depressive symptoms through disruption of brain networks that regulate emotional functions. However, we do not yet know to what degree the emotion regulation brain network is modified by the restoration of sleep, or whether the degree to which a sleep intervention modifies these neural targets mediates reductions in other depressive symptoms including suicidality.

The overall aim is to test the efficacy of an established sleep intervention (Cognitive Behavioral Therapy for Insomnia (CBT-I)) in reducing depressive symptoms through improving emotion regulation brain function in individuals with elevated depressive symptoms and clinically meaningful sleep disturbance.

In this study, we will assess feasibility of recruitment and retention as well as target engagement. Target engagement is defined as the treatment effect on increasing mPFC-amygala connectivity, and/or decreasing amygdala reactivity during emotion reactivity and regulation paradigms. Participants will be 70 adults experiencing at least moderate sleep disturbances and who also have elevated anxious and/or depressive symptoms. Emotion distress and sleep disruption will be assessed prior to, and weekly while receiving six Cognitive Behavioral Therapy for Insomnia (CBT-I) across a period of 8 weeks. CBT-I improves sleep patterns through a combination of sleep restriction, stimulus control, mindfulness training, cognitive therapy targeting dysfunctional beliefs about sleep, and sleep hygiene education. Using fMRI scanning, emotion regulation network neural targets will be assayed prior to and following completion of CBT-I treatment.


The Role of the Circadian System in Binge Eating Disorder

Study Type: Interventional
Start Date: January 15, 2021
Eligibility: 18 Years to 50 Years, Accepts Healthy Volunteers
Location(s): Lindner Center of HOPE / University of Cincinnati, Mason, Ohio, United States

Binge eating disorder (BED) shows prominent circadian features that suggest a delay in circadian phase, and preliminary evidence shows binge eating may be responsive to chronobiological interventions, implicating a circadian system dysfunction in its pathophysiology. What remains lacking, however, is comprehensive knowledge of the characteristics of circadian system dysfunction in BED, and whether this dysfunction represents a therapeutic target in BED. There is therefore a critical need to characterize circadian system dysfunction in BED, and evaluate it as a potential therapeutic target. Without such information, the understanding on the role of the circadian system in BED and its potential as a new therapeutic target will remain limited.


Studying Childhood-onset Behavioral, Psychiatric, and Developmental Disorders

Study Type: Observational
Start Date: December 27, 2012
Eligibility: 99 Years and Younger, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

- Many psychiatric, behavioral, and developmental disorders are genetic. This means that they tend to run in families. Some begin in childhood, while others do not appear until adulthood. Researchers want to look at people of all ages who have these disorders that started in childhood. They will also look at relatives of people with these disorders. This information will allow doctors to learn more about childhood behavioral problems and how they are inherited. It may also help doctors treat those disorders.

Objectives:

- To study the onset and treatment of childhood behavioral, psychiatric, and developmental disorders.

Eligibility:

Individuals of any age who have a psychiatric, autism spectrum, or developmental disorder, or other behavioral problems. Family members of individuals with the above disorders. This group may include parents, grandparents, siblings, aunts/uncles, cousins, and children.

Design:

Participants will be screened with a medical history and physical exam. They will have a psychiatric history with tests of thinking, judgment, and behavior. Blood and urine samples will be collected. Brain imaging scans will be performed to look at brain function. They may have a spinal tap to collect cerebrospinal fluid. Relatives will have a medical history and physical exam. They will also have a psychiatric history with tests of thinking, judgment, and behavior. Blood and urine samples will be collected. Brain imaging scans will be performed to look at brain function. A relative s exams may reveal a behavioral or other disorder. If so, he or she may re-enroll on the study as a person with the disorder.


Family Study of Affective and Anxiety Spectrum Disorders

Study Type: Observational
Start Date: May 21, 2004
Eligibility: 7 Years to 120 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

This study will examine how depression, anxiety, and migraine run in families. It will help in defining the risk factors for physical, mental, and health problems-as well as define ways that those problems may be prevented and treated.

A broad range of ages among family members will be included to evaluate the patterns of how these disorders are expressed throughout people's lives. Children of all ages will be included, and those ages 8 to 17 will be interviewed directly.

Assessments will be collected through criteria of the Diagnostic and Statistical Manual of Mental Disorders IV as well as the spectrum, or range, of mood disorders and co-existing conditions. A member of the study team will visit the participants at home or will do an interview by telephone. Participation will take approximately 3 to 4 hours. Children will complete questionnaires given by the research team as well as questionnaires that they will do by themselves. The questions will pertain to the children's health, including physical and mental health and medical history, social relationships, problems, skills, and ways of dealing with important or stressful issues in their lives. These questionnaires will take up to 1 hour to complete.

Health history gathered from adult participants will pertain to height, weight, exercise, and general function. Women will be asked about the use of oral contraceptives, estrogen, and progesterone. In addition, there will be questionnaires on personality and temperamental traits, that is, behavior and impulsiveness. Questions will also involve social intuition, family and other environmental factors, general functioning, and basic demographics such as ethnicity, race, socioeconomic status, marital status, education level, and employment history.

Families enrolled in this phase of the research will be invited to participate in the next phase. There would be follow-up to evaluate the development of mood disorders, subtypes, and syndromes across the lifespan.