NCT00001920

Brief Summary

The purpose of this study is to explore how the brain works during particular memory tasks in people with schizophrenia and healthy volunteers. Research has shown that patients with schizophrenia have structural and functional abnormalities in the hippocampus and cerebellum of their brains. These abnormalities are likely associated with the memory impairment experienced by these patients. Eye blink tests can provide information about memory acquisition involving the cerebellar and hippocampal regions. By altering the stimuli interval, these tests can distinguish between cerebellum-dependent memory associated with subliminal mnemonic encoding and hippocampus-dependent memory associated with conscious awareness. This study will use eyeblink tests to determine which type of memory is predominantly affected in schizophrenia. Participants in this study will be screened with a physical and psychiatric examination. Participants will have an electroencephalogram (EEG), an electrocardiogram (ECG), and an electrodermal test. Evoked potentials and magnetic resonance imaging (MRI) scans of the brain may also be taken.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 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

August 30, 1999

Completed
2 months 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
10.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2010

Completed
Last Updated

July 2, 2017

Status Verified

June 2, 2010

First QC Date

November 3, 1999

Last Update Submit

June 30, 2017

Conditions

Keywords

SchizophreniaEyeblinkEvoked PotentialsLearningNormal VolunteerHealthy Volunteer

Eligibility Criteria

Age18 Years - 60 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. Medical histories will be evaluated by the investigators 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.
  • Age 18-60.
  • No family history of schizophrenia by subject report and possibly also by collateral report by at least one other family member.
  • Patients:
  • Schizophrenia, any subtype or schizoaffective disorder, depressed type by DSM IV (110).
  • Only concomitant medications should be neuroleptics and medications directed at controlling side effects (e.g. anticholinergics). An effort will be made to recruit patients on atypical neuroleptics, therefore attempting to minimize the anticholinergics, which might interfere with the acquisition of a conditioned response. When patients on anticholinergic treatment will be recruited as inpatients, a clinical evaluation of the risks and benefits of suspending anticholinergic treatment will be made and discussed with the patient. Anticholinergics will be withdrawn for a period equivalent to 3 half lives of the drug before attempting the study, if this is judged to be achievable with a relatively low risk and the patient agrees.
  • Age18-60.

You may not qualify if:

  • Controls and Patients:
  • Impaired hearing.
  • Use of caffeine or tobacco in the 2 hours preceding the test.
  • Head trauma with loss of consciousness in the last year, or any evidence of functional impairment due to and persisting after head trauma.
  • All subjects who are unable to withstand the eyeblink testing will be excluded. Subjects who are not able to participate in the MRI (e.g. due to claustrophobia) will be studied to achieve a larger group for the behavioral experiments.
  • Subjects who are found to have eye lesions on exam.
  • 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 MRI 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, excluding neuroleptics.
  • Presence of diskinetic 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).
  • Pregnancy testing will be performed on women of childbearing age within the three days prior to MRI scanning.
  • +1 more criteria

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)

  • Woodruff-Pak DS. Classical conditioning. Int Rev Neurobiol. 1997;41:341-66. doi: 10.1016/s0074-7742(08)60359-1.

    PMID: 9378597BACKGROUND
  • Chen L, Bao S, Lockard JM, Kim JK, Thompson RF. Impaired classical eyeblink conditioning in cerebellar-lesioned and Purkinje cell degeneration (pcd) mutant mice. J Neurosci. 1996 Apr 15;16(8):2829-38. doi: 10.1523/JNEUROSCI.16-08-02829.1996.

    PMID: 8786457BACKGROUND
  • Daum I, Schugens MM, Ackermann H, Lutzenberger W, Dichgans J, Birbaumer N. Classical conditioning after cerebellar lesions in humans. Behav Neurosci. 1993 Oct;107(5):748-56. doi: 10.1037//0735-7044.107.5.748.

    PMID: 8280385BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

August 30, 1999

Study Completion

June 2, 2010

Last Updated

July 2, 2017

Record last verified: 2010-06-02

Locations