Schizophrenia
Conditions
Keywords
Negative symptoms, neuropsychological deficits, Cognitive function, diagnostic, prevention
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.
Interventions
DRUGRisperidone
Risperidone will be given in low dosage to a random sample of family members of Schizophrenic patients
Sponsors
Ortho-McNeil Janssen Scientific Affairs, LLC
Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 59 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neuropsychological - cognitive measures | 2003-2010 |
Secondary
| Measure | Time frame |
|---|---|
| Psychiatric Symptoms | 2003-2010 |
Countries
China
Contacts
Primary ContactLingjiang Li, MD, PhD
Backup ContactLiwen Tan, MD, PhD
Outcome results
None listed