Identification and Treatment of the Liability to Develop Schizophrenia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Central South University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Central South University
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by:
Central South University
ClinicalTrials.gov Identifier:
NCT00305474
First received: March 21, 2006
Last updated: June 23, 2009
Last verified: June 2009
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Diagnostic |
| Official Title: | Identification and Treatment of the Liability to Develop Schizophrenia |
Resource links provided by NLM:
MedlinePlus related topics:
Schizophrenia
Drug Information available for:
Risperidone
U.S. FDA Resources
Further study details as provided by Central South University:
Primary Outcome Measures:
- Neuropsychological - cognitive measures [ Time Frame: 2003-2010 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Psychiatric Symptoms [ Time Frame: 2003-2010 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2003 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Risperidone
Risperidone will be given in low dosage to a random sample of family members of Schizophrenic patients
Eligibility| Ages Eligible for Study: | 19 Years to 59 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00305474
Contacts
| 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 |
Locations
| 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 | |
Sponsors and Collaborators
Central South University
Ortho-McNeil Janssen Scientific Affairs, LLC
Investigators
| Principal Investigator: | William Stone, PhD | Harvard Medical School |
| Study Chair: | Lingjiang Li, MD, PhD | Central South Unversity |
More Information
No publications provided
| Responsible Party: | William Stone, PhD, Beth Israel- Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT00305474 History of Changes |
| Other Study ID Numbers: | XYMHI001 |
| Study First Received: | March 21, 2006 |
| Last Updated: | June 23, 2009 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Central South University:
|
Negative symptoms neuropsychological deficits Cognitive function diagnostic prevention |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Risperidone Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 22, 2013