NCT00305474UnknownPhase 4
Identification and Treatment of the Liability to Develop Schizophrenia
Central South University1 site in 1 country100 target enrollmentStarted: December 1, 2003Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Neuropsychological - cognitive measures
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 59 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Having at least one first-degree biological relative with schizophrenia and their age is between 19 and
- •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
- •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.
Outcomes
Primary Outcomes
Neuropsychological - cognitive measures
Time Frame: 2003-2010
Secondary Outcomes
- Psychiatric Symptoms(2003-2010)
Investigators
Study Sites (1)
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