Identification and Treatment of the Liability to Develop Schizophrenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Brief Summary

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This study seeks to determine whether adult, non-psychotic, first-degree relatives of schizophrenic patients who show specific neurocognitive deficits and negative symptoms will show improvements in these areas following a 6-month, double-blind trial of a low dose (up to 2.0 mg) of risperidone.

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Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Risperidone

Risperidone will be given in low dosage to a random sample of family members of Schizophrenic patients

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Having at least one first-degree biological relative with schizophrenia and their age is between 19 and 59.
* Desire to participate in a medication trial.
* Is able to provide informed consent.
* Having moderate levels of negative symptoms, defined as 6 items rated 3 or higher on the Scale for the Assessment of Negative Symptoms (SANS).
* Scoring two or more standard deviations below normal in at least one of three cognitive domains: vigilance/working memory, long-term verbal memory, and executive functions.
* Scoring at least one standard deviation below normal in a second cognitive domain.

Exclusion Criteria

* IQ less than 80.
* Formal education less than 10 years.
* History of psychotic disorders.
* History of treatment with an antipsychotic medication.
* A substance abuse diagnosis within 6 months of diagnosis.
* A head injury with documented loss of consciousness exceeding 5 minutes (or subsequent cognitive deficits).
* A history of neurologic disease or damage.
* A medical condition with significant cognitive sequelae.
* A history of electroconvulsive treatment.

Minimum Eligible Age

19 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes