Identification and Treatment of the Liability to Develop Schizophrenia

Phase 4

• Conditions: Schizophrenia

• Registration Number: NCT00305474
• Lead Sponsor: Central South University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2006-03-21
• Study First Submitted QC: 2006-03-21
• Study First Posted: 2006-03-22
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-23
• Last Update Posted: 2009-06-24
• Primary Completion: 2010-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Neuropsychological - cognitive measures	2003-2010

Secondary Outcome Measures

Name	Time	Method
Psychiatric Symptoms	2003-2010

Trial Locations

Locations (1)

Mental Health Institute; 🇨🇳 Changsha, Hunan, China