Recruiting

Observational Study

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT01409109

Conditions

Schizophrenia

Schizoaffective Disorder

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Study Details

Brief summary:

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.

Conditions

Schizophrenia

Schizoaffective Disorder

Study ID

NCT01409109

Start date

Mar, 2010

Status verified date

Apr, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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 Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Patient volunteers

This group is comprised of persons with Schizophrenia and Schizoaffective.

Healthy volunteers

This group is comprised of individuals who have no current or past psychiatric diagnosis.

Primary outcome measure

  • Differences in hippocampal subfield activation between people with schizophrenia (or schizoaffective disorder) and healthy volunteers [ Time Frame: Participants will be assessed over the course of 4-6 weeks, until all study procedures are complete ]

Central Contacts and Locations

Central contacts

Elena Ivleva, M.D., Ph.D.

214-645-8942elena.ivleva@utsouthwestern.edu

Debra Bushong, M.S., L.P.C.

214-648-4653debra.bushong@utsouthwestern.edu

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Elena Ivleva, M.D., Ph.D.

214-645-8942elena.ivleva@utsouthwestern.edu

Debra Bushong, M.S., L.P.C.

214-648-4653debra.bushong@utsouthwestern.edu

Principal Investigator:

Carol A. Tamminga, M.D.

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

  • Schizophrenia
  • Schizoaffective
  • Neuroimaging
  • Magnetic Resonance Imaging (MRI)
  • Functional Magnetic Resonance Imaging (fMRI)
  • Spectroscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-04-23.