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 Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Diagnostic
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: January 2010
- Drug: Risperidone
- Risperidone will be given in low dosage to a random sample of family members of Schizophrenic patients
Clinical Trial Outcome Measures
- Neuropsychological – cognitive measures
- Time Frame: 2003-2010
- Psychiatric Symptoms
- Time Frame: 2003-2010
Participating in This Clinical Trial
- 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.
- 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.
Gender Eligibility: All
Minimum Age: 19 Years
Maximum Age: 59 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Central South University
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Provider of Information About this Clinical Study
- William Stone, PhD, Beth Israel- Deaconess Medical Center
- Overall Official(s)
- William Stone, PhD, Principal Investigator, Harvard Medical School
- Lingjiang Li, MD, PhD, Study Chair, Central South Unversity
- Overall Contact(s)
- Lingjiang Li, MD, PhD, 011-86-731-555-0413, firstname.lastname@example.org
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