Database Registry for Neural Network Biomarkers in Psychosis
Database Registry to Examine Brain Connections and Brain Function in Mental Disorders and Neural Network Biomarkers for Relational Memory and Psychosis in Schizophrenia
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 60 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: MRI scans, Interviews
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Several observations have been made with magnetic resonance imaging (MRI) that characterize brain connections and brain function in individuals with schizophrenia and other mental disorders."
- "The proposed project entails the collection of clinical interview data, behavioral data, blood, magnetic resonance imaging (MRI) data, and functional magnetic resonance imaging (fMRI) data from 1000 volunteers, both patient volunteers and healthy normal volunteers."
- "The volunteers will undergo a series of clinical interviews to determine their diagnosis, behavioral task training, medical workup, and standard structural and functional magnetic resonance imaging."
- "The volunteers will be trained to criteria on the tasks, at which point they will have the option to complete the MRI and fMRI portions of the study."
- "In conjunction with one of the fMRI scans we will also conduct a cerebral blood volume (CBV) MRI to investigate blood perfusion in the medial temporal lobe of volunteers with mental illness to compare to normal control volunteers."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study collects brain scans, blood, and information from interviews and thinking tasks from people with and without mental illness. It looks at how brain areas work and connect in mental illness, including schizophrenia. The data will be stored for current and future research; this study does not test a treatment.
Several observations have been made with magnetic resonance imaging (MRI) that characterize brain connections and brain function in individuals with schizophrenia and other mental disorders. For example, research investigating schizophrenia focuses on the dysfunction of connections within and between the medial temporal lobe and the prefrontal cortex as well as other pertinent brain regions. This database registry will allow for the collection of clinical interview data, behavioral data, blood, magnetic resonance imaging (MRI) data, and functional magnetic resonance imaging (fMRI) data on individuals with and without mental disorders to better understand how connections in the brain and various brain regions function differently while volunteers perform various cognitive tasks. This is an observational study that is being conducted to collect data and place it in a registry for current and future investigational questions related to imaging in mental disorders.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Mental illness group: Have a diagnosis of schizophrenia or schizoaffective disorder, which affects thinking and mood.
- Mental illness group: Be able to understand the study and agree to take part.
- Healthy group: Have no past or current severe mental illness.
- Both groups: People of all races and ethnic backgrounds may join.
- Both groups: Have vision of 20/40 or better, with glasses or contacts if needed.
- Both groups: Be able to read, speak, and understand English.
Who can't join
- Both groups: Have a disease that physically affects the brain.
- Both groups: Have a serious illness that is not stable.
- Both groups: Have had a serious head injury.
- Both groups: Be pregnant.
- Mental illness group: Have a diagnosis of alcohol or drug abuse within the past month, or alcohol or drug dependence within the past 3 months.
- Healthy group: Have any history of mental illness.
- Healthy group: Currently use drugs that affect the mind, other than nicotine or caffeine.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: Volunteers with Schizophrenia or other mental illness * Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) diagnosis of Schizophrenia or Schizoaffective disorder * Competent to give informed consent * All races and ethnicities * Eyesight corrected to 20-40 or better * Able to read, speak, and understand English Healthy volunteers * No past or current severe mental illness * All races and ethnicities * Eyesight corrected to 20-40 or better * Able to read, speak, and understand English Exclusion Criteria: Volunteers with schizophrenia or other mental illness * Diagnosis of an organic brain disease * Diagnosis of DSM-IV-TR alcohol or substance abuse within the last month or DSM-IV-TR alcohol or substance dependence within the last three months * Serious, unstable medical illness * History of serious head injury * Pregnant women Healthy volunteers * History of psychiatric illness * Current use of psychoactive drugs excluding nicotine and caffeine * Diagnosis of an organic brain disease * Serious, unstable medical illness * History of serious head injury * Pregnant women
Study sites (1)
TX
- University of Texas Southwestern Medical Center · Dallas, TX 75390Elena Ivleva, M.D., Ph.D. · Study contact · 214-645-8942 · elena.ivleva@utsouthwestern.eduDebra Bushong, M.S., L.P.C. · Study contact · 214-648-4653 ext. Bushong · debra.bushong@utsouthwestern.eduCarol A. Tamminga, M.D. · Principal investigatorElena Ivleva, M.D., Ph.D. · Sub-investigatorMore trials in Dallas