Registry of brain 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
This project will collect MRI, fMRI, blood, and clinical data to try to identify brain connectivity biomarkers in people with schizophrenia or schizoaffective disorder and healthy volunteers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT01409109 on ClinicalTrials.gov |
What this trial studies
This observational registry will enroll about 1,000 volunteers, including people with schizophrenia or schizoaffective disorder and healthy controls, to collect clinical interviews, behavioral data, blood samples, and both structural MRI and task-based fMRI. Participants will complete cognitive tasks with button responses and visual stimuli while undergoing standard and functional whole-brain MRI; no changes to participants' medications will be made as part of participation. Data will be curated into a registry to support current analyses and future investigations of neural network connectivity and task-related activation patterns. The protocol emphasizes standardized task training and imaging acquisition to enable pooling across subjects for biomarker discovery.
Who should consider this trial
Good fit: Ideal participants are adults with a DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder who can give informed consent, have corrected vision of 20/40 or better, speak and read English, and are medically stable for MRI.
Not a fit: Patients with organic brain disease, recent substance dependence or abuse, serious unstable medical illness, a history of serious head injury, pregnancy, or inability/unwillingness to complete MRI-based tasks are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the registry could reveal imaging biomarkers that help diagnose or track psychosis and guide future development of targeted treatments.
How similar studies have performed: Previous neuroimaging studies have consistently found altered connectivity and task-related activation in schizophrenia, but robust, clinically validated neural-network biomarkers are not yet established, so this registry builds on existing findings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dallas, Texas
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Carol A. Tamminga, M.D. — UT Southwestern
- Study coordinator: Elena Ivleva, M.D., Ph.D.
- Email: elena.ivleva@utsouthwestern.edu
- Phone: 214-645-8942
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.