NCT00001284

Brief Summary

The purpose of this study is to use brain imaging technology to compare differences in brain structure, chemistry, and functioning in individuals with brain and mental disorders compared to healthy volunteers. Schizophrenia is a brain disorder that results from subtle changes and abnormalities in neurons. These deficits likely occur in localized regions of the brain and may result in widespread, devastating consequences. The neuronal abnormalities are inherited through a complex combination of genetic and environmental factors. Brain imaging technologies can be used to better characterize brain changes in individuals with schizophrenia. This study will use magnetic resonance imaging (MRI) scans to identify predictable, quantifiable abnormalities in neurophysiology, neurochemistry and neuroanatomy that characterize schizophrenia and other neurological and neuropsychiatric disorders....

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,802

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 1991

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 10, 1991

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
19.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2019

Completed
Last Updated

December 17, 2019

Status Verified

February 25, 2019

First QC Date

November 3, 1999

Last Update Submit

December 14, 2019

Conditions

Keywords

CognitionSchizophreniaMagnetic Resonance ImagingMagnetic Resonance SpectroscopyDopaminergic Mechanisms

Outcome Measures

Primary Outcomes (1)

  • Brain Activation

    Per MRI Scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CONTROLS:
  • No psychiatric or severe chronic medical illness at the time of the study, and by history. This includes the absence of substance abuse histories, learning disabilities and all DSM IV disorders. The investigators will evaluate medical histories and medical conditions that are judged not to interfere with the study may be allowed.
  • No use of psychotropic substances in the last 3 months.
  • There is no upper age limit. The lower age limit is 18 years.
  • PATIENTS:
  • Schizophrenia, any subtype or schizoaffective disorder according to DSM IV, as detailed in protocol # 89-M-0160 ("Inpatient Evaluation of Neuropsychiatric Inpatients") and #95-M-0150 ("A Longitudinal Investigation of Siblings of Schizophrenic and Manic-Depressive Patients").
  • Bipolar Disorder with Psychotic Features according to DSM IV as detailed in protocol.
  • Menstrually-Related Mood Disorder.
  • Mild to Moderate Parkinson's Disease (Hoehn and Yahr Stage 1-3).

You may not qualify if:

  • CONTROLS AND PATIENTS:
  • Impaired hearing.
  • Pregnancy.
  • Head trauma with loss of consciousness in the last year, or any evidence of functional impairment due to and persisting after head trauma.
  • Patients or healthy volunteers with a known risk from exposure to high magnetic fields (e.g. patients with pace makers) and those who have metallic implants (e.g. braces) in the head region (likely to create artifact on the MRI scans) will be excluded from participating in the fMRI studies.
  • Patients:
  • Coexistence of another major mental illness at the time of the study. If the patients experienced other mental illnesses in the past (e.g. major depression), then this should be judged to be fully recovered.
  • Criteria for substance abuse met in the last 6 months.
  • Criteria for substance dependence in the last year. If criteria for dependence were met in the past, then the duration of the disorder was less than 3 years, or not judged to have produced long-term brain changes to allow the patient to be in the study.
  • Major concurrent medical illness likely to interfere with the acquisition of the task.
  • Concomitant medications which could interfere with performance on the task.
  • Presence of dyskinetic movements of the face and tongue (likely to interfere with eyeblink measures, or of gross involuntary movements of the whole body (likely to interfere with positioning in the MRI scanner).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Belliveau JW, Kennedy DN Jr, McKinstry RC, Buchbinder BR, Weisskoff RM, Cohen MS, Vevea JM, Brady TJ, Rosen BR. Functional mapping of the human visual cortex by magnetic resonance imaging. Science. 1991 Nov 1;254(5032):716-9. doi: 10.1126/science.1948051.

    PMID: 1948051BACKGROUND
  • Ogawa S, Tank DW, Menon R, Ellermann JM, Kim SG, Merkle H, Ugurbil K. Intrinsic signal changes accompanying sensory stimulation: functional brain mapping with magnetic resonance imaging. Proc Natl Acad Sci U S A. 1992 Jul 1;89(13):5951-5. doi: 10.1073/pnas.89.13.5951.

    PMID: 1631079BACKGROUND
  • Kwong KK, Belliveau JW, Chesler DA, Goldberg IE, Weisskoff RM, Poncelet BP, Kennedy DN, Hoppel BE, Cohen MS, Turner R, et al. Dynamic magnetic resonance imaging of human brain activity during primary sensory stimulation. Proc Natl Acad Sci U S A. 1992 Jun 15;89(12):5675-9. doi: 10.1073/pnas.89.12.5675.

    PMID: 1608978BACKGROUND

MeSH Terms

Conditions

Brain DiseasesSchizophrenia

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Karen F Berman, M.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

May 10, 1991

Study Completion

February 25, 2019

Last Updated

December 17, 2019

Record last verified: 2019-02-25

Locations