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| Sponsors and Collaborators: |
Central South University Janssen, LP |
|---|---|
| Information provided by: | Central South University |
| ClinicalTrials.gov Identifier: | NCT00305474 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Risperidone |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Eligibility| Ages Eligible for Study: | 19 Years to 59 Years |
| Genders Eligible for Study: | Both |
| Accepts 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, or a history of electroconvulsive treatment.
Contacts and Locations| Contact: Lingjiang Li, MD, PhD | 011-86-731-555-0413 | lilj9016@public.cs.hn.cn |
| Contact: Liwen Tan, MD, PhD | 011-86-13874870034 | gangbie7788@yahoo.com.cn |
| China, Hunan | |
| Mental Health Institute | Recruiting |
| Changsha, Hunan, China, 410011 | |
| Contact: Liwen Tan, MD, PhD 01186-13874870034 gangbie7788@yahoo.com.cn | |
| Principal Investigator: Liwen Tan, MD, PhD | |
| Sub-Investigator: Ning Ma, MD | |
| Sub-Investigator: You Yin, MD | |
| Sub-Investigator: Wenjuan Yu, MD | |
| Sub-Investigator: Feng Wan, MD | |
| Sub-Investigator: Yan Zhang, MD, MS | |
| Principal Investigator: | Ming T. Tsuang, MD, PhD | UCSD |
| Study Director: | William Stone, PhD | Harvard University |
| Study Chair: | Lingjiang Li, MD, PhD | Central South Unversity |
More Information
| Study ID Numbers: | XYMHI001 |
| Study First Received: | March 21, 2006 |
| Last Updated: | March 21, 2006 |
| ClinicalTrials.gov Identifier: | NCT00305474 |
| Health Authority: | China: Ministry of Health |
|
Negative symptoms neuropsychological deficits Cognitive function diagnostic prevention |
|
Schizophrenia Dopamine Mental Disorders Risperidone |
Psychotic Disorders Serotonin Schizophrenia and Disorders with Psychotic Features |
|
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |
