NCT01409109

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
35mo left

Started Mar 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Mar 2010Apr 2029

Study Start

First participant enrolled

March 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
17.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

19.1 years

First QC Date

June 29, 2011

Last Update Submit

April 20, 2026

Conditions

Keywords

SchizophreniaSchizoaffectiveNeuroimagingMagnetic Resonance Imaging (MRI)Functional Magnetic Resonance Imaging (fMRI)Spectroscopy

Outcome Measures

Primary Outcomes (1)

  • Differences in hippocampal subfield activation between people with schizophrenia (or schizoaffective disorder) and healthy volunteers

    This study will investigate the alterations in the medial temporal lobe, specifically the differences in hippocampal subfield activation, between patients with psychosis (Schizophrenia and Schizoaffective disorder), their relatives and normal volunteers. We hypothesize that there will be an increase in perfusion and a decrease in subfield activation in the people with psychosis.

    Participants will be assessed over the course of 4-6 weeks, until all study procedures are complete

Secondary Outcomes (1)

  • Differences in glutamate neurotransmitters and glutamatergic function between people with schizophrenia (or schizoaffective disorder) and with healthy volunteers

    Participants will be assessed over the course of 4-6 weeks, until all study procedures are complete

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Individuals who have been diagnosed with the following disorders will be enrolled in this study: Schizophrenia and Schizoaffective disorder.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Carol A. Tamminga, M.D.

    UT Southwestern

    PRINCIPAL INVESTIGATOR
  • Elena Ivleva, M.D., Ph.D.

    UT Southwestern

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

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

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 29, 2011

First Posted

August 3, 2011

Study Start

March 1, 2010

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations