Status:
COMPLETED
Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia
Lead Sponsor:
Central South University
Collaborating Sponsors:
Shanghai Mental Health Center
Sichuan University
Conditions:
Schizophrenia
Eligibility:
All Genders
16-50 years
Phase:
PHASE4
Brief Summary
Antipsychotic alone is limit to improve the overall outcome of schizophrenia and has a high discontinue rate.To solve these problems, we provide practical and available psychosocial intervention. We h...
Detailed Description
The study is designed as a national, multicenter, randomized, naturalistic trial, with research assessors intended to be blind to the intervention status. We plan to recruit 1400 patients at 10 china...
Eligibility Criteria
Inclusion
- Eligible patients were 16 to 50 years of age;
- had received a diagnosed of schizophrenia in accordance with criteria set out in the Diagnostic and Statistical Manual of Mental Disorders-fourth edition (DSM-IV);
- were confirmed to be clinically stable by the investigator (the total score ≤60 on the Positive and Negative Syndrome Scale \[PANSS\] or a decrease of fifty percent from acute period in the total score on PANSS)
- and taken maintenance treatment with any one of the following seven oral antipsychotics:
- chlorpromazine
- sulpiride clozapine
- risperidone
- olanzapine
- quetiapine
- aripiprazole
Exclusion
- Patients were excluded if they had received a diagnosis of schizoaffective disorder, mental retardation, or other cognitive disorders;
- had a history of serious adverse reactions to the proposed treatment;
- were pregnant or breastfeeding; or had a serious and unstable medical condition.
- Patients were excluded if they were unable to provide informed consent
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
1400 Patients enrolled
Trial Details
Trial ID
NCT00654576
Start Date
February 1 2005
End Date
December 1 2007
Last Update
April 8 2008
Active Locations (1)
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1
Institute of Mental Health of The Second Xiangya Hospital, Central South University
Changsha, Hunan, China, 410011