Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia (ACPIOS)
|ClinicalTrials.gov Identifier: NCT00654576|
Recruitment Status : Completed
First Posted : April 8, 2008
Last Update Posted : April 8, 2008
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole Behavioral: psychosocial intervention||Phase 4|
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 sites and randomly assign them to two group. the control group only receive antipsychotic and the study group receive antipsychotic combination with psychosocial intervention. The course is 12 months. Patients use one of the seven study drugs (chlorpromazine, sulpiride, clozapine, olanzapine, risperidone, quetiapine, and aripitrazole)to the maintain treatment. The psychosocial intervention include psychoeducation, family intervention, skills training, and cognitive-behavioral therapy. The primary aim is to delineate differences in the overall effectiveness of the two treatment model.The assessments include the outcome of symptomatology，neurobiology，social psychology，medical economics.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1400 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia:One-Year Follow up.|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
Active Comparator: 1
the comparator arm will only receive one of the seven antipsychotic
Drug: Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole
patient will receive one of the seven study drugs (Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole) as the maintain treatment. the dose is flexible, is based on the study doctor's judgment.
the experimental group will receive one of the seven study drugs combination with psychosocial intervention
Behavioral: psychosocial intervention
the psychosocial interventions include psychoeducaiton, family intervention, skill training, and cognitive-behavioral therapy.
- the time to discontinued treatment and the rate of relapse/rehospitalization
- clinical psychopathology, side effect, compliance, social function, neurocognitive function, quality of life, family/career burden, cost analysis.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00654576
|Institute of Mental Health of The Second Xiangya Hospital, Central South University|
|Changsha, Hunan, China, 410011|