NCT00001921

Brief Summary

This study will explore how the brain works during memory testing in an effort to understand why some patients with schizophrenia have memory difficulties. Patients with schizophrenia and their unaffected family members are eligible for this study. Studying family members may help identify the genes related to the memory deficit in schizophrenia. Normal volunteers will also be studied. Normal volunteers, patients with schizophrenia, and their family members interested in participating in this study will be screened with a complete medical examination and psychiatric assessment, and performance of simple tasks. Study participants will be shown numbers on a screen and asked to recall them after a brief period. This will be done during electroencephalographic (EEG) recording, in which electrodes attached to the scalp measure the brain s electrical activity. The same test will be repeated while the patient has magnetic resonance imaging of the brain. The combined MRI and EEG testing will permit better localization of the brain s electrical activity. ...

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,386

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 1999

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

September 21, 1999

Completed
1 month 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
18.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2018

Completed
Last Updated

December 17, 2019

Status Verified

June 8, 2018

First QC Date

November 3, 1999

Last Update Submit

December 14, 2019

Conditions

Keywords

Functional ConnectivityFrontotemporal InteractionElectrophysiologyFunctional Magnetic Resonance ImagingHealthy SubjectsSchizophreniaMEGNeuroimagingEEGMRI

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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", Dr. Jose Apud, principal investigator) and # 95-M-0150 ("A Longitudinal Investigation of Siblings of Schizophrenic and Manic-Depressive Patients", Dr. Daniel R. Weinberger, principal investigator).

You may not qualify if:

  • Controls and patients:
  • Impaired hearing.
  • Pregnancy (only for purpose of MRI procedures under separate protocols)
  • 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. a learning disability or 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 met 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 (4)

  • Rutter L, Nadar SR, Holroyd T, Carver FW, Apud J, Weinberger DR, Coppola R. Graph theoretical analysis of resting magnetoencephalographic functional connectivity networks. Front Comput Neurosci. 2013 Jul 12;7:93. doi: 10.3389/fncom.2013.00093. eCollection 2013.

    PMID: 23874288BACKGROUND
  • Siebenhuhner F, Weiss SA, Coppola R, Weinberger DR, Bassett DS. Intra- and inter-frequency brain network structure in health and schizophrenia. PLoS One. 2013 Aug 26;8(8):e72351. doi: 10.1371/journal.pone.0072351. eCollection 2013.

    PMID: 23991097BACKGROUND
  • Altamura M, Carver FW, Elvevag B, Weinberger DR, Coppola R. Dynamic cortical involvement in implicit anticipation during statistical learning. Neurosci Lett. 2014 Jan 13;558:73-7. doi: 10.1016/j.neulet.2013.09.043. Epub 2013 Sep 27.

    PMID: 24080375BACKGROUND
  • 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.

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
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

September 21, 1999

Study Completion

June 8, 2018

Last Updated

December 17, 2019

Record last verified: 2018-06-08

Locations