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Schizophrenia

Schizophrenia is a serious mental illness that affects how a person thinks, feels, and behaves. People with schizophrenia may seem like they have lost touch with reality, which can be distressing for them and for their family and friends. The symptoms of schizophrenia can make it difficult to participate in usual, everyday activities, but effective treatments are available. Learn more about schizophrenia.

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Featured Studies

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


Anti-Inflammatory Challenge in Schizophrenia 

Study Type: Interventional
Start Date: March 31, 2024
Eligibility: 18 Years to 45 Years, Does Not Accept Healthy Volunteers
Location(s): Emory University Hospital, Atlanta, Georgia, United States; Grady Memorial Hospital, Atlanta, Georgia, United States

This research project will explore negative symptoms of schizophrenia, such as motivational deficits, by examining the relationship between inflammation and reward-related brain regions. To accomplish this, we will administer a single infusion of either the anti-inflammatory medication infliximab or placebo (n=10 per group) to patients with high inflammation.

This study is important because schizophrenia can be a chronic and debilitating neuropsychiatric disorder and negative symptoms are some of the most difficult aspects of schizophrenia associated with worst functional outcomes. These symptoms do not typically respond to antipsychotic therapies, and as such, there are no current medications to treat negative symptoms.


Young Adults With Violent Behavior During Early Psychosis 

Study Type: Interventional
Start Date: February 29, 2024
Eligibility: 16 Years to 30 Years, Does Not Accept Healthy Volunteers
Location(s): New York State Psychiatric Institute, New York, New York, United States

This study aims to provide an evidence-based behavioral intervention to reduce violent behavior for individuals experiencing early psychosis.


Enhanced Coordinated Specialty Care for Early Psychosis 

Study Type: Interventional
Start Date: February 1, 2024
Eligibility: Age N/A, Does Not Accept Healthy Volunteers
Location(s): Massachusetts General Hospital FEPP Clinic, Boston, Massachusetts, United States; McLean Hospital OnTrack Clinic, Belmont, Massachusetts, United States

The goal of this clinical trial is to compare engagement in treatment in coordinated specialty care (CSC) to five extra care elements (CSC 2.0) in first-episode psychosis. The main question it aims to answer is:

• Does the addition of certain elements of care increase the number of visits in treatment for first-episode psychosis?

Participants will either:

Receive care as usual (CSC) or

Receive care as usual (CSC) plus five additional care elements (CSC 2.0):

Individual peer support Digital outreach Care coordination Multi-family group therapy Cognitive remediation

Researchers will compare the standard of care (CSC) to CSC 2.0 to see if participants receiving CSC 2.0 have more visits to their clinic in their first year.


Accelerated Transcranial Magnetic Stimulation for People With Schizophrenia Treated With Clozapine 

Study Type: Interventional
Start Date: December 1, 2023
Eligibility: 18 Years to 50 Years, Does Not Accept Healthy Volunteers
Location(s): UPMC Western Psychiatric Hospital/University of Pittsburgh, Pittsburgh, Pennsylvania, United States

In this study, the investigators will examine whether a type of repetitive transcranial magnetic stimulation called accelerated intermittent theta burst stimulation (iTBS) can augment neurocognition in individuals who receive treatment with clozapine. Following a baseline evaluation and magnetic resonance imaging (MRI), participants will undergo a session of iTBS +MRI and session of sham delivery + MRI. The order for these sessions will be blinded and randomized. The investigators predict that accelerated iTBS will enhance neurocognition relative to sham delivery.


Auditory Control Enhancement (ACE) in Schizophrenia 

Study Type: Interventional
Start Date: September 5, 2023
Eligibility: 18 Years to 40 Years, Does Not Accept Healthy Volunteers
Location(s): Western Psychiatric Hospital of UPMC, Pittsburgh, Pennsylvania, United States

The purpose of this clinical trial is to investigate neural markers of target engagement to further develop auditory control enhancement (ACE) as a novel, inexpensive, and noninvasive intervention to address treatment-refractory auditory hallucinations. Here, we will address questions about the feasibility and acceptability of ACE, as well as the degree to which ACE results in measurable engagement of biophysical and neurophysiological targets.

Participants will complete:

Auditory Control Enhancement (ACE): Participants will be assigned by chance (such as a coin flip) into one of two groups to receive a different dosage or level of transcranial direct current stimulation (tDCS) during three sessions of cognitive training. tDCS is used to stimulate the brain for a short period of time. For tDCS one or two thin wet sponges are placed on the head and/or upper arm. The sponges will be connected to electrodes which will deliver a very weak electrical current. The Neuroelectrics Starstim 32 will be used to deliver tDCS. Interviews: Before and after ACE, in two separate sessions, participants will be asked questions about a) background; b) functioning in daily life and across different phases of your life and past, present and future medical records. Cognitive Tests: During the interview sessions, participants will also perform cognitive tests. Participants will be asked to complete computerized and pen-and-paper tests of attention, concentration, reading, and problem-solving ability. EEG scan: Participants will be asked to complete EEG (electroencephalography) studies before and after ACE training. EEG will be measured using the same Neuroelectrics Starstim 32 system used for tDCS. EEG measures the natural activity of the brain using small sensors placed on the scalp. These sensors use conductive gel to provide a connection suitable for recording brain activity. During EEG, participants will watch a silent video while sounds are played over headphones, or sometimes count the sounds. In addition to these auditory tasks, participants will also be asked to perform visual attention tasks, such pressing a button for a letter or image. Magnetic Resonance Imaging (MRI) Scan: Participants will also be asked to complete MRI studies before and after ACE training. An MRI is a type of brain scan that takes pictures of the brain that will later be used to create a 3D model of the brain. The MRI does not use radiation, but rather radio waves, a large magnet and a computer to create the images.

Researchers will compare individuals receiving ACE to those receiving sham tDCS during cognitive training to determine effects of ACE.


Restoring Spindle and Thalamocortical Efficiency in Early-Course Schizophrenia Patients Using Auditory Stimulation 

Study Type: Interventional
Start Date: July 20, 2023
Eligibility: 18 Years to 40 Years, Accepts Healthy Volunteers
Location(s): University of Pittsburgh, Pittsburgh, Pennsylvania, United States

The purpose of this research is to identify differences in brain activity during sleep between health individuals and individuals with schizophrenia, schizophreniform, or schizoaffective disorder. This study will also investigate whether tones played during deep sleep can enhance specific features of sleep and whether enhancing such features is related to an improvement in cognitive performance.


EPI-MINN: Targeting Cognition and Motivation - National 

Study Type: Interventional
Start Date: May 30, 2023
Eligibility: 15 Years to 40 Years, Does Not Accept Healthy Volunteers
Location(s): University of Minnesota Department of Psychiatry & Behavioral Sciences, Minneapolis, 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 receiving care at coordinated specialty care (CSC) early psychosis clinics across the United States will be recruited to participate in this study. A qualifying CSC program will provide comprehensive clinical services such as psychotherapy, medication management, psychoeducation, and work or education support. This study will be conducted remotely, and participants can participate at home with their own electronic devices.

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. Participants will complete a screening interview which will include diagnosis and symptom ratings, neurocognitive assessment, and self-reports of symptoms, behavior, and functioning. Then participants will be randomized to receive the 12-week mobile intervention, or an active control of treatment as usual. The investigators will test for differences in the clinical trajectories after training, and at two follow up appointments at 6 and 12 months post-training.


Improving Cognition Through Telehealth Aerobic Exercise and Cognitive Training After a First Schizophrenia Episode 

Study Type: Interventional
Start Date: May 23, 2023
Eligibility: 18 Years to 45 Years, Does Not Accept Healthy Volunteers
Location(s): UCLA Aftercare Research Program, Los Angeles, California, United States

The participants in the study will receive psychiatric treatment at the UCLA Aftercare Research Program. All participants in this 12-month RCT will receive cognitive training. Half of the patients will also be randomly assigned to the aerobic exercise and strength training condition, and the other half will be randomly assigned to the Healthy Living Group condition. The primary outcome measures are improvement in cognition and level of engagement in the in-group and at-home exercise sessions. Increases in the level of the patient's serum brain-derived neurotropic factor (specifically Mature BDNF) which causes greater brain neuroplasticity and is indicator of engagement in aerobic exercise, will be measured early in the treatment phase in order to confirm engagement of this target. In order to demonstrate the feasibility and portability of this intervention outside of academic research programs, the interventions will be provided via videoconferencing. The proposed study will incorporate additional methods to maximize participation in the exercise condition, including the use of the Moderated Online Social Therapy (MOST) platform to enhance motivation for treatment based on Self-Determination Theory principles, and a "bridging" group to help the participants generalize gains to everyday functioning. In addition, the exercise group participants will receive personally tailored text reminders to exercise.


Deep Brain Stimulation in Treatment Resistant Schizophrenia 

Study Type: Interventional
Start Date: March 1, 2023
Eligibility: 22 Years to 65 Years, Does Not Accept Healthy Volunteers
Location(s): The Johns Hopkins Hospital, Baltimore, Maryland, United States

The purpose of this pilot study is to investigate the use of deep brain stimulation (DBS) of the substantia nigra pars reticulata (SNr) in subjects with treatment-resistant schizophrenia. There is a subset of patients with schizophrenia who continue to have persistent psychotic symptoms (auditory hallucinations and delusions) despite multiple adequate medication trials with antipsychotic medications including clozapine. There are currently no available treatments for such patients who generally have poor function and are chronically disabled, unable to work, live independently or have meaningful social relationships. Neuroimaging studies in patients with schizophrenia have revealed information about pathological neural circuits that could be suitable targets using deep brain stimulation. Although not yet tested in patients with schizophrenia, DBS is in early phase clinical trials in other psychiatric disorders.

This pilot study will investigate the use of DBS in treatment-resistant schizophrenia subjects who have exhausted all other therapeutic alternatives but continue to have persistent disabling psychotic symptoms. Of note, DBS is not FDA approved for use in patients with schizophrenia. The method will be similar to that used in subthalamic nucleus stimulation in patients with Parkinson's Disease. However, the electrode will be advanced slightly inferior into the SNr, a major outflow nucleus of the basal ganglia, with the intention of causing local inhibition of SNr outflow resulting in disinhibition of the mediodorsal nucleus (MDN) of the thalamus. Hypofunction of the MDN has been implicated in the pathophysiology of schizophrenia in post-mortem as well as multiple structural and functional imaging studies. Evidence suggests that dysfunction of the MD is implicated in both positive and cognitive symptoms (such as working memory impairment) in schizophrenia. Frequent monitoring and clinical assessment with psychiatric scales will be used to monitor treatment response.


Song-making In a Group (SING) 

Study Type: Interventional
Start Date: October 14, 2022
Eligibility: 18 Years to 65 Years, Does Not Accept Healthy Volunteers
Location(s): Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut, United States

The overarching aim of the proposed work is to align a promising treatment lead - Musical Intervention (MI) - with a promising mechanistic account of psychosis - Predictive Processing. This protocol focuses on the R33 phase, to optimize its administration (Is active participation more effective than passive listening? Does creation of new music help more than performing others' creations?). By tracking the interrelation between symptom mechanisms and MI, the investigators can use those metrics to prospectively assign patients to particular MI.

The R33 phase will examine the impact of SING on computational behavioral metrics of (Aim 1) Conditioned Hallucinations, (Aim 2) Social Reinforcement Learning, (Aim 3) Language Use, in 200 participants with voice hearing in the context of a psychotic illness (n=50per per group). Following a screening visit to determine eligibility, these computerized tasks will be administered behaviorally, and an interview will elicit speech, prior to and following the full SING intervention (in 10 groups of 5 participants, each facilitated by a trained musical interventionist, during the first two years of the project).

Participants will complete these tasks prior to and following randomization to four different conditions (facilitated by a SING team member) that will deconstruct the possible active ingredients of SING along two dimensions: Activity and Ownership: (a) SING (n=50, Activity + and Ownership +), participants produce and perform their own song; (b) Karaoke (n=50, Activity + and Ownership -), participants perform karaoke, singing along to others music; (c) Pop Music (n=50, Activity - and Ownership -), participants will listen to popular music chosen by the music interventionists; and (d) Curated Playlists (n=50, Activity -, Ownership +), participants will curate playlists of popular music and listen to them together.

This deconstruction will provide insights into the predictive processing framework, as applied to hallucinations and music, specifically, whether changes at higher, a-modal, hierarchical levels, particularly sense of self and active inference, influence precision weighted perceptual and social inferences more so than inactive experiences or experiences that do not engage sense of self.

This R33 portion of the study was originally included in NCT05537428, which now has results posted for the R61 phase of the study.


What the Nose Knows: Hedonic Capacity, Psychosocial Interventions and Outcomes in Schizophrenia 

Study Type: Interventional
Start Date: September 2, 2022
Eligibility: 18 Years to 65 Years, Does Not Accept Healthy Volunteers
Location(s): Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

This project proposes to conduct the first study of the predictive utility of olfactory hedonic measurement for targeted psychosocial rehabilitation in schizophrenia. The information gathered from the project is of considerable public health relevance, in that, through simple, reliable olfactory assessment, it will provide knowledge about which individuals are most likely to benefit from these psychosocial interventions. Such information is crucial for tailoring existing interventions and developing new approaches to optimize outcomes in schizophrenia.


State Representation in Early Psychosis - Project 4 

Study Type: Interventional
Start Date: July 31, 2022
Eligibility: 15 Years to 45 Years, Accepts Healthy Volunteers
Location(s): University of Minnesota, Minneapolis, Minnesota, United States

The purpose of this study is to examine state representation in individuals aged 15-45 who have been diagnosed with a psychotic illness, as well as young adults who do not have a psychiatric diagnosis. State Representation is our ability to process information about our surroundings. The investigators will complete a clinical trial examining two paradigms of cognitive training.


Remote State Representation in Early Psychosis 

Study Type: Interventional
Start Date: July 27, 2022
Eligibility: 18 Years to 30 Years, Does Not Accept Healthy Volunteers
Location(s): University of Minnesota, Minneapolis, Minnesota, United States

The purpose of this study is to examine state representation in individuals aged 15-40 who have been diagnosed with a psychotic illness, as well as young adults who do not have a psychiatric diagnosis. State Representation is our ability to process information about our surroundings. The investigators will complete some observational tests as well as a cognitive training clinical trial.


Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial 

Study Type: Interventional
Start Date: March 17, 2022
Eligibility: 18 Years to 65 Years, Does Not Accept Healthy Volunteers
Location(s): New York State Psychiatric Institute, New York, New York, United States

Two-hundred and eighty individuals with schizophrenia who have a recent history of violent acts will be randomized in this 2-arm, parallel-group, 24-week, open-label, 7-site clinical trial to examine the effects of treatment with clozapine vs antipsychotic treatment as usual (TAU) for reducing the risk of violent acts in real-world settings


Academic-Community EPINET (AC-EPINET) 

Study Type: Interventional
Start Date: March 16, 2022
Eligibility: 16 Years to 35 Years, Does Not Accept Healthy Volunteers
Location(s): Early Psychosis Intervention Clinic-New Orleans (EPIC-NOLA) - Tulane University, New Orleans, Louisiana, United States; Prevention and Recovery Center for Early Psychosis, Indianapolis, Indiana, United States; Vanderbilt's Early Psychosis Program - Vanderbilt University, Nashville, Tennessee, United States; The Early Psychosis Intervention Center (EPICENTER) at Ohio State, Columbus, Ohio, United States; Strong Ties Young Adults Program- University of Rochester Medical Center, Rochester, New York, United States; Program for Risk Evaluation and Prevention (PREP) - University of Michigan, Ann Arbor, Michigan, United States

The investigators propose to examine the effects of CSC services delivered via TH (CSC-TH) versus the standard clinic-based CSC model (CSC-SD) on engagement and outcomes in a 12-month, randomized trial.


Antipsychotic Response to Clozapine in B-SNIP Biotype-1 (Clozapine) 

Study Type: Interventional
Start Date: March 1, 2022
Eligibility: 18 Years to 60 Years, Does Not Accept Healthy Volunteers
Location(s): UT Southwestern Medical Center, Dallas, Texas, United States

The CLOZAPINE study is designed as a multisite study across 5 sites and is a clinical trial, involving human participants who are prospectively assigned to an intervention. The study will utilize a stringent randomized, double-blinded, parallel group clinical trial design. B2 group will serve as psychosis control with risperidone as medication control. The study is designed to evaluate effect of clozapine on the B1 participants, and the effect that will be evaluated is a biomedical outcome. The study sample will be comprised of individuals with psychosis, including 1) schizophrenia, 2) schizoaffective disorder and 3) psychotic bipolar I disorder. The investigators plan to initially screen and recruit n=524 (from both the existing B-SNIP library and newly-identified psychosis cases, ~50% each) in order to enroll n=320 (B1 and B2) into the RCT.


State Representation in Early Psychosis 

Study Type: Interventional
Start Date: December 1, 2021
Eligibility: 15 Years to 45 Years, Accepts Healthy Volunteers
Location(s): University of Minnesota, Minneapolis, Minnesota, United States

The purpose of this study is to examine state representation in individuals aged 15-45 who have been diagnosed with a psychotic illness, as well as young adults who do not have a psychiatric diagnosis. State Representation is our ability to process information about our surroundings. The investigators will complete some observational tests as well as a cognitive training clinical trial.


Enhancing Prefrontal Oscillations and Working Memory in Early-course Schizophrenia 

Study Type: Interventional
Start Date: November 5, 2021
Eligibility: 18 Years to 40 Years, Does Not Accept Healthy Volunteers
Location(s): University of Pittsburgh, Pittsburgh, Pennsylvania, United States

This study will investigate the effects of intermittent Theta Burst Stimulation (iTBS) on natural oscillatory frequency of the dorsolateral prefrontal cortex (DLPFC) and working memory in early-course schizophrenia (EC-SCZ). Transcranial magnetic stimulation (TMS) will be used to evoke oscillatory activity, and EEG will record the responses of EC-SCZ participants. A working memory task will also be incorporated in order to determine how DLPFC natural frequency (NF) is related to working memory performance. iTBS (active or sham) will be administered, then the oscillatory activity of DLPFC and working memory performance will be reassessed. The overarching goal is to determine whether iTBS can acutely enhance the oscillatory activity of the DLPFC and to evaluate the relationship between changes in the DLPFC and working memory performance.


Targeting Processing Speed Deficits to Improve Social Functioning and Lower Psychosis Risk 

Study Type: Interventional
Start Date: October 28, 2021
Eligibility: 14 Years to 20 Years, Does Not Accept Healthy Volunteers
Location(s): Northwell Health- The Zucker Hillside Hospital, Glen Oaks, New York, United States

This 10 week intervention, Specific Cognitive Remediation with Surround (or SCORES), is designed to target processing speed, a cognitive domain related directly to social functioning, which in turn, represents a vulnerability factor for psychosis. This remotely-delivered intervention combining targeted cognitive training exercises and group support was developed to directly impact processing speed, and at the same time, boost motivation and engagement in adolescents at risk for schizophrenia and other psychotic disorders.


Using Transcranial Magnetic Stimulation (TMS) to Understand Hallucinations in Schizophrenia 

Study Type: Interventional
Start Date: October 13, 2021
Eligibility: 18 Years to 55 Years, Does Not Accept Healthy Volunteers
Location(s): McLean Hospital, Belmont, Massachusetts, United States

This study uses a noninvasive technique called transcranial magnetic stimulation (TMS) to study how hallucinations work in schizophrenia.

TMS is a noninvasive way of stimulating the brain, using a magnetic field to change activity in the brain. The magnetic field is produced by a coil that is held next to the scalp. In this study the investigators will be stimulating the brain to learn more about how TMS might improve these symptoms of schizophrenia.


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.


M1 Schizophrenia PET Study 

Study Type: Interventional
Start Date: April 20, 2021
Eligibility: 18 Years to 65 Years, Accepts Healthy Volunteers
Location(s): Connecticut Mental Health Center, New Haven, Connecticut, United States

This exploratory study seeks to examine M1 receptor availability in SZ patients and to relate M1 receptor availability to proximal and distal measures of cognitive performance, namely evoked ɣ oscillations in the EEG and verbal memory. Furthermore, the relationship between hippocampal [11C]EMO availability (BPND), evoked ɣ oscillations, verbal memory, and measures of illness severity will be explored.


A Translational and Neurocomputational Evaluation of a Dopamine Receptor 1 Partial Agonist for Schizophrenia 

Study Type: Interventional
Start Date: March 2, 2021
Eligibility: 18 Years to 45 Years, Does Not Accept Healthy Volunteers
Location(s): Columbia University, New York, New York, United States; Yale University, New Haven, Connecticut, United States; Stony Brook University, Stony Brook, New York, United States; University of Pennsylvania, Philadelphia, Pennsylvania, United States

This study will test whether CVL-562 (PF-06412562), a dopamine 1 partial agonist novel compound, affects working memory neural circuits in patients with early episode schizophrenia. The overall aim is to establish neuroimaging biomarkers of the Dopamine Receptor 1/Dopamine Receptor 5 Family (D1R/D5R) target engagement to accelerate development of D1R/D5R agonists in humans to treat cognitive impairments that underlie functional disability in schizophrenia, a key unaddressed clinical and public health concern.


Family-Focused Therapy for Individuals at High Clinical Risk for Psychosis: A Confirmatory Efficacy Trial 

Study Type: Interventional
Start Date: January 15, 2021
Eligibility: 13 Years to 25 Years, Does Not Accept Healthy Volunteers
Location(s): Harvard University/Beth Israel Deconess Medical Center, Boston, Massachusetts, United States; University of California, Los Angeles, Los Angeles, California, United States; University of Calgary, Calgary, Alberta, Canada; Zucker Hillside Hospital, New York, New York, United States; Yale University, New Haven, Connecticut, United States; University of California, San Francisco School of Medicine, San Francisco, California, United States; University of California, San Diego, San Diego, California, United States

The present study is a confirmatory efficacy trial of Family Focused Therapy for youth at clinical high risk for psychosis (FFT-CHR). This trial is sponsored by seven mature CHR clinical research programs from the North American Prodrome Longitudinal Study (NAPLS). The young clinical high risk sample (N = 220 youth ages 13-25) is to be followed at 6-month intervals for 18 months.


Medial-prefrontal Enhancement During Schizophrenia Systems Imaging 

Study Type: Interventional
Start Date: November 12, 2020
Eligibility: 18 Years to 64 Years, Accepts Healthy Volunteers
Location(s): UCSF, San Francisco, California, United States

This randomized controlled trial in healthy controls (HC) and patients with schizophrenia (SZ) aims to examine 1) the underlying cognitive and neural cause of self-agency deficits in SZ; 2) the responsiveness to a novel navigated repetitive transcranial magnetic stimulation (nrTMS) target in the medial/superior prefrontal cortex (mPFC); and 3) how modulation of mPFC activity impacts the larger self-agency network to mediate changes in self-agency judgments. Our overall hypothesis is that increased mPFC excitability by active high-frequency nrTMS in HC and SZ will induce behavioral improvements in self-agency and neural changes in the larger self-agency network that will generalize to improvements in overall cognition, symptoms and daily functioning, and will likely lead to the development of new effective neuromodulation therapies in patients with schizophrenia.


Early-Phase Schizophrenia: Practice-based Research to Improve Outcomes 

Study Type: Observational
Start Date: April 1, 2020
Eligibility: 15 Years to 40 Years
Location(s): Henderson Behavioral Health, Lauderdale Lakes, Florida, United States

The goal if the project is to develop a learning health network devoted to the treatment of first episode psychosis.


Multi-modal Assessment of Gamma-aminobutyric Acid (GABA) Function in Psychosis 

Study Type: Interventional
Start Date: January 16, 2020
Eligibility: 16 Years to 60 Years, Accepts Healthy Volunteers
Location(s): University of Michigan, Ann Arbor, Michigan, United States

The purpose of this study is to better understand mental illness and will test the hypotheses that while viewing affective stimuli, patient groups will show increased blood oxygenation level dependent (BOLD) signal by fMRI after lorazepam.

This study will enroll participants between the ages of 16 and 60, who have a psychotic illness (such as psychosis which includes conditions like schizophrenia, schizoaffective disorder, and mood disorders). The study will also enroll eligible participants without any psychiatric illness, to compare their brains.

The study will require participants to have 3-4 sessions over a few weeks. The initial assessments (may be over two visits) will include a diagnostic interview and several questionnaires (qols) to assess eligibility. Subsequently, there will will be two separate functional magnetic resonance imaging (fMRI) sessions in which lorazepam or placebo will be given prior to the MRI. During the fMRI the participants will also be asked to answer questions. Additionally, the participants will have their blood drawn, women of child bearing potential will have a urine pregnancy test, vital signs taken, and asked to complete more qols.


Promoting Activity and Cognitive Enrichment in Schizophrenia (PACES) 

Study Type: Interventional
Start Date: October 1, 2019
Eligibility: 18 Years to 60 Years, Does Not Accept Healthy Volunteers
Location(s): University of Pittsburgh, Pittsburgh, Pennsylvania, United States

This project will conduct a confirmatory efficacy trial of two novel psychosocial interventions, Cognitive Enhancement Therapy and Enriched Supportive Therapy, for the treatment of persistent negative symptoms in schizophrenia.


Remediation of Visual Perceptual Impairments in People With Schizophrenia 

Study Type: Interventional
Start Date: June 1, 2018
Eligibility: 18 Years to 60 Years, Does Not Accept Healthy Volunteers
Location(s): New York Presbyterian Hospital, White Plains, New York, United States

The purpose of this study is to evaluate the effectiveness of a visual remediation intervention for people with schizophrenia. The intervention targets two visual functions that much research has shown are impaired in many people with the disorder, namely contrast sensitivity and perceptual organization. The first phase of the study will test the effects of interventions targeting each of these processes, as well as the effects of a combined package. A control condition of higher-level cognitive remediation is included as a fourth condition. The second phase of the study will evaluate the effectiveness of the most effective intervention from the first phase, but in a new and larger sample of individuals. Outcome measures include multiple aspects of visual functioning, as well as visual cognition and overall community functioning.


Neuronal Effects of Exercise in Schizophrenia 

Study Type: Interventional
Start Date: August 31, 2014
Eligibility: 21 Years to 70 Years, Does Not Accept Healthy Volunteers
Location(s): University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

This study plans to learn more about how common drugs prescribed to individuals with schizophrenia contribute to weight gain, as well as how exercise and diet impact appetite and the brain's response to food. In this study, the investigators will be evaluating how participants' brains respond to food images as well as asking questions about their food preferences and intake and clinical symptoms. The investigators may also ask participants to complete an exercise or diet intervention to see how this changes brain responses or food preferences.


Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning 

Study Type: Observational
Start Date: July 31, 2010
Eligibility: Males, 18 Years to 55 Years, Accepts Healthy Volunteers
Location(s): Connecticut Mental Health Center, Clinical Neuroscience Research Unit, New Haven, Connecticut, United States

The aim of the present study is to assess the availability of cannabinoid receptors (CB1R) in the human brain. CB1R are present in everyone's brain, regardless of whether or not someone has used cannabis. The investigators will image brain cannabinoid receptors using Positron Emission Tomography (PET) imaging and the radioligand OMAR, in healthy individuals and several conditions including 1) cannabis use disorders, 2) psychotic disorders, 3) prodrome of psychotic illness and 4) individuals with a family history of alcoholism, 5) Post-Traumatic Stress Disorder 6) Opioid Use Disorder using the PET imaging agent or radiotracer, [11C]OMAR. This will allow us to characterize the number and distribution of CB1R in these conditions. It is likely that the list of conditions will be expanded after the collection of pilot data and as new data on cannabinoids receptor function and psychiatric disorders becomes available.

Those in the cannabis us disorder arm of the study will have a PET scan on at least three occasions: once while smoking as usual, once after 48-hours of abstinence from cannabis, and a final time after 4 weeks of abstinence. Additional scans may be conducted within the 4 weeks and the last scan may be conducted well beyond 4 weeks. Similarly, while most schizophrenia patients may get scanned just once, a subgroup of patients may get scanned more than once. For example to tease out the effects of medications, unmedicated patients may get scanned while unmedicated and again after treatment with antipsychotic medications. Similarly prodromes may get scanned while in the prodromal stage off medications, on medications and after conversion to schizophrenia.


Functional Relevance of Dopamine Receptors in Healthy Controls and Patients With Schizophrenia: Characterization Through [11C]NNC-112 and [18F]Fallypride Positron Emission Tomography 

Study Type: Observational
Start Date: November 13, 2009
Eligibility: 18 Years to 90 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Background:

Some illnesses, such as schizophrenia, have effects on brain cells called dopamine receptors, which are required for normal brain function. People with schizophrenia have difficulty thinking and experience hallucinations and delusions. Medications that change brain dopamine receptors can decrease these hallucinations and delusions. The cause of schizophrenia and its association with brain dopamine receptors is not known but may be clarified by studying dopamine receptors in people who have dopamine disorders (such as schizophrenia) and those who do not. Researchers are interested in studying the dopamine system to gain a better idea of how dopamine disorders develop, which may lead to better medical care for people with schizophrenia.

Objectives:

- To study the amount and distribution of two types of dopamine receptors.

Eligibility:

Individuals between the ages of 18 and 60 who have schizophrenia. Healthy volunteers between the ages of 18 and 90.

Design:

Participants will undergo a full screening, with physical and psychological history, a neurological examination, and blood and urine samples. Participants will have a blood flow map of the brain recorded with a positron emission tomography (PET) brain scan. A magnetic resonance imaging (MRI) scan will also be performed to determine brain anatomy. To study the amount and distribution of dopamine receptors in the brain, participants will receive a small amount of a radioactive chemical in the vein, followed by a PET scan. The procedure will be performed twice in two separate sessions, once for [18F]fallypride and once for [11C]NNC-112.


PET Scanning in Parkinson s Disease 

Study Type: Observational
Start Date: March 15, 2002
Eligibility: 18 Years to 90 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

This is an in vivo positron emission tomography (PET) study of regional cerebral dopamine and blood flow in normal volunteers, persons with Parkinson s disease (both familial and sporadic), and those with schizophrenia spectrum disorders. The latter also sign consent for NIH approved protocol 89-M-0160, "Inpatient Evaluation of Neuropsychiatric Patients," PI: Daniel Eisenberg, M.D. Using PET with 6-[F-18] Fluoro-L-dopa (FDOPA) and (15)0-H2O in a single scan session, both presynaptic dopaminergic function and regional cerebral blood flow (rCBF) are assessed. The kinetic rate constant (Ki) for presynaptic dopaminergic uptake in striatum and other regions is calculated. We compare Ki across subject groups and relate the findings to rCBF. Findings are also related to allelic variation in genes of interest, for determination of which participants sign separate consent for NIH approved protocol 95-M-0150 Neurobiological Investigation of Patients with Schizophrenia Spectrum Disorders and Their Siblings, PI: Karen F. Berman, MD. We also draw comparisons between subjects with inherited vs. sporadic Parkinson s disease to determine whether the PET phenotype is the same in both groups, and we compare system-level, circuit-based pathophysiology across PD and schizophrenia groups. Each subject is further screened with an MRI to rule out structural abnormalities and also to further delineate areas of interest in the PET scans.


Magnetic Resonance Imaging (MRI) of Neuropsychiatric Patients and Healthy Volunteers 

Study Type: Observational
Start Date: February 17, 2000
Eligibility: 18 Years and Older, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

The purpose of this study is to use brain imaging technology to compare differences in brain structure, chemistry, and functioning in individuals with brain and mental disorders compared to healthy volunteers.

Schizophrenia is a brain disorder that results from subtle changes and abnormalities in neurons. These deficits likely occur in localized regions of the brain and may result in widespread, devastating consequences. The neuronal abnormalities are inherited through a complex combination of genetic and environmental factors. Brain imaging technologies can be used to better characterize brain changes in individuals with schizophrenia. This study will use magnetic resonance imaging (MRI) scans to identify predictable, quantifiable abnormalities in neurophysiology, neurochemistry and neuroanatomy that characterize schizophrenia and other neurological and neuropsychiatric disorders.


Genetic Study of Schizophrenia 

Study Type: Observational
Start Date: July 15, 1995
Eligibility: 18 Years to 55 Years, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

This large ongoing study at NIMH investigates the neurobiology of schizophrenia by identifying susceptibility genes, evaluating their impact on brain function to better understand how to treat and prevent this illness.


Brain Imaging of Childhood Onset Psychiatric Disorders, Endocrine Disorders and Healthy Volunteers 

Study Type: Observational
Start Date: June 19, 1990
Eligibility: 3 Years and Older, Accepts Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Magnetic Resonance Imaging (MRI) unlike X-rays and CT-scans does not use radiation to create a picture. MRI use as the name implies, magnetism to create pictures with excellent anatomical resolution. Functional MRIs are diagnostic tests that allow doctors to not only view anatomy, but physiology and function. It is for these reasons that MRIs are excellent methods for studying the brain.

In this study, researchers will use MRI to assess brain anatomy and function in X and Y chromosome variation, healthy volunteers, and patients with a variety of childhood onset psychiatric disorders. The disorders include attention deficit disorder, autism, congenital adrenal hyperplasia, childhood-onset schizophrenia, dyslexia, obsessive compulsive disorder, Sydenham's chorea, and Tourette's syndrome.

Results of the MRIs showing the anatomy of the brain and brain function will be compared across age, sex (gender), and diagnostic groups. Correlations between brain and behavioral measures will be examined for normal and clinical populations....


Inpatient Evaluation of Adults With Schizophrenia 

Study Type: Observational
Start Date: September 15, 1989
Eligibility: 18 Years to 120 Years, Does Not Accept Healthy Volunteers
Location(s): National Institutes of Health Clinical Center, Bethesda, Maryland, United States

The purpose of this study is to understand the biologic basis of schizophrenia and to determine which symptoms are related to the illness itself and which are related to medications used to treat the illness.

Schizophrenia and related psychoses are chronic brain disorders whose prognosis is often poor and whose pathophysiology remains obscure. Brain imaging technologies such s positron emission tomography (PET), functional magnetic resonance imaging (fMRI), and magnetic resonance imaging (MRI) offer opportunities to study the pathophysiology of psychotic disorders by evaluating brain function. However, the use of anti-psychotic drugs may interfere with the results of such studies. In this study, psychotropic medication will be discontinued in patients for a short period of time to distinguish the effects of the illness on the brain without the interference of the medication's effects on the brain. Given that there is a risk that the patient's symptoms will increase, they are asked to stay on an inpatient unit where the NIMH clinical staff is available to help them 24 hours a day.

This study will be conducted in three phases. In Phase 1, participants will be admitted to the Clinical Center while continuing to take their medication and will undergo diagnostic interviews, physical and laboratory assessments, physiological monitoring, and neuropsychological testing. Behavioral ratings will also be performed and blood and urine samples will be collected. During Phase 2, participants will continue taking medications in a blinded fashion for 8 to 12 weeks. The active medications will be replaced with a placebo (an inactive pill) part of that time. PET, fMRI, and MRI scans will be used to monitor how the continuation or lack of medication affects the brain. Psychological tests will also be given to measure changes in cognition. In Phase 3, participants will have the opportunity for clinical stabilization....