Registry of brain network biomarkers in psychosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.