NCT00004571

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

80
On Track

Trial Health Score

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

Enrollment
3,273

participants targeted

Target at 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

First Submitted

Initial submission to the registry

February 15, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2000

Completed
1 day until next milestone

Study Start

First participant enrolled

February 17, 2000

Completed
Last Updated

May 22, 2026

Status Verified

September 9, 2025

First QC Date

February 15, 2000

Last Update Submit

May 20, 2026

Conditions

Keywords

fMRIMEGCognitionMagnetic Resonance ImagingSchizophreniaNatural History

Outcome Measures

Primary Outcomes (5)

  • regional MRSI measures

    GABA and glutamate measurements in schizophrenia and healthy controls.

    spectroscopy

  • magnetic field potentials

    Group differences in MEG signal for patients with schizophrenia and healthy subjects.

    MEG

  • fMRI BOLD responses

    Group differences between patients with schizophrenia and healthy subjects, also genotyping used to characterize subjects as well.

    MRI study completion

  • DTI anisotropy measures

    Compare fractional anisotropy and other measures of white matter connectivity for schizophrenic patients and controls.

    DTI

  • brain volumetric measures

    VBM and cortical parcellation are used in schizophrenia and healthy controls.

    VBM

Secondary Outcomes (1)

  • neuropsychological task performance data

    NPT

Study Arms (3)

Healthy volunteers

Healthy subjects from the community

Schizophrenia

Patients with schizophrenia and psychosis

Williams Syndrome

Individuals with copy number variation in the Williams Syndrome Region

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with schizophrenia and healthy subjects from the community.

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.
  • Controls will all have the capacity to consent.
  • PATIENTS:
  • Schizophrenia, any subtype or schizo-affective disorder according to DSM IV .
  • Bipolar Disorder with Psychotic Features according to DSM IV.
  • Menstrually-Related Mood Disorder.
  • Mild to Moderate Parkinson's Disease (Hoehn and Yahr Stage 1-3).
  • Williams Syndrome (partial or full) with IQ in the normal range.
  • Patients with Multiple Sclerosis.

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.
  • History of any (excepting nicotine-related) DSM5-defined moderate to severe substance use disorder (or DSM-IV-defined substance dependence).
  • Cumulative lifetime history of any (excepting nicotine-related) DSM5-defined mild substance use disorder (or any DSM-IV-defined substance abuse), either in excess of 5 years total or not in remission for at least 6 months.
  • NIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy.
  • Non-NIMH NIH employees and staff may participate and will be given the NIH Frequently Asked Questions (FAQs) for NIH Staff Who are Considering Participation in NIH Research.
  • 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. a learning disability or major depression), then this should be judged to be fully recovered.
  • Major concurrent medical illness likely to interfere with the acquisition of the task.
  • Concomitant medications which could interfere with performance on the task.
  • Involuntary movements that 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

Bethesda, Maryland, 20892, United States

Location

Related Publications (8)

  • Ianni AM, Eisenberg DP, Boorman ED, Constantino SM, Hegarty CE, Gregory MD, Masdeu JC, Kohn PD, Behrens TE, Berman KF. PET-measured human dopamine synthesis capacity and receptor availability predict trading rewards and time-costs during foraging. Nat Commun. 2023 Sep 30;14(1):6122. doi: 10.1038/s41467-023-41897-0.

  • Kippenhan JS, Gregory MD, Nash T, Kohn P, Mervis CB, Eisenberg DP, Garvey MH, Roe K, Morris CA, Kolachana B, Pani AM, Sorcher L, Berman KF. Dorsal visual stream and LIMK1: hemideletion, haplotype, and enduring effects in children with Williams syndrome. J Neurodev Disord. 2023 Aug 26;15(1):29. doi: 10.1186/s11689-023-09493-x.

  • Rubinstein DY, Eisenberg DP, Carver FW, Holroyd T, Apud JA, Coppola R, Berman KF. Spatiotemporal Alterations in Working Memory-Related Beta Band Neuromagnetic Activity of Patients With Schizophrenia On and Off Antipsychotic Medication: Investigation With MEG. Schizophr Bull. 2023 May 3;49(3):669-678. doi: 10.1093/schbul/sbac178.

  • Marenco S, Meyer C, van der Veen JW, Zhang Y, Kelly R, Shen J, Weinberger DR, Dickinson D, Berman KF. Role of gamma-amino-butyric acid in the dorsal anterior cingulate in age-associated changes in cognition. Neuropsychopharmacology. 2018 Oct;43(11):2285-2291. doi: 10.1038/s41386-018-0134-5. Epub 2018 Jul 3.

  • Jabbi M, Cropp B, Nash T, Kohn P, Kippenhan JS, Masdeu JC, Mattay R, Kolachana B, Berman KF. BDNF Val66Met polymorphism tunes frontolimbic circuitry during affective contextual learning. Neuroimage. 2017 Nov 15;162:373-383. doi: 10.1016/j.neuroimage.2017.08.080. Epub 2017 Sep 1.

  • Wei SM, Baller EB, Kohn PD, Kippenhan JS, Kolachana B, Soldin SJ, Rubinow DR, Schmidt PJ, Berman KF. Brain-derived neurotrophic factor Val66Met genotype and ovarian steroids interactively modulate working memory-related hippocampal function in women: a multimodal neuroimaging study. Mol Psychiatry. 2018 Apr;23(4):1066-1075. doi: 10.1038/mp.2017.72. Epub 2017 Apr 18.

  • Jabbi M, Chen Q, Turner N, Kohn P, White M, Kippenhan JS, Dickinson D, Kolachana B, Mattay V, Weinberger DR, Berman KF. Variation in the Williams syndrome GTF2I gene and anxiety proneness interactively affect prefrontal cortical response to aversive stimuli. Transl Psychiatry. 2015 Aug 18;5(8):e622. doi: 10.1038/tp.2015.98.

  • Jabbi M, Kohn PD, Nash T, Ianni A, Coutlee C, Holroyd T, Carver FW, Chen Q, Cropp B, Kippenhan JS, Robinson SE, Coppola R, Berman KF. Convergent BOLD and Beta-Band Activity in Superior Temporal Sulcus and Frontolimbic Circuitry Underpins Human Emotion Cognition. Cereb Cortex. 2015 Jul;25(7):1878-88. doi: 10.1093/cercor/bht427. Epub 2014 Jan 23.

Related Links

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia 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
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2000

First Posted

February 16, 2000

Study Start

February 17, 2000

Last Updated

May 22, 2026

Record last verified: 2025-09-09

Locations