Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia
NCT ID: NCT00654576
Last Updated: 2008-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1400 participants
INTERVENTIONAL
2005-02-28
2007-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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1
the comparator arm will only receive one of the seven antipsychotic
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.
2
the experimental group will receive one of the seven study drugs combination with psychosocial intervention
psychosocial intervention
the psychosocial interventions include psychoeducaiton, family intervention, skill training, and cognitive-behavioral therapy.
Interventions
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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.
psychosocial intervention
the psychosocial interventions include psychoeducaiton, family intervention, skill training, and cognitive-behavioral therapy.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
16 Years
50 Years
ALL
No
Sponsors
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Shanghai Mental Health Center
OTHER
Sichuan University
OTHER
Capital Medical University
OTHER
Nanjing Medical University
OTHER
Jiangxi Mental Hospital
UNKNOWN
Hunan Mental Hospital
OTHER
Guangzhou Mental Hospital
OTHER
Chongqing Metal Institute
UNKNOWN
Henan Mental Hospital
UNKNOWN
Central South University
OTHER
Locations
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Institute of Mental Health of The Second Xiangya Hospital, Central South University
Changsha, Hunan, China
Countries
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References
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Zhang Z, Zhai J, Wei Q, Qi J, Guo X, Zhao J. Cost-effectiveness analysis of psychosocial intervention for early stage schizophrenia in China: a randomized, one-year study. BMC Psychiatry. 2014 Jul 26;14:212. doi: 10.1186/s12888-014-0212-0.
Guo X, Fang M, Zhai J, Wang B, Wang C, Hu B, Sun X, Lv L, Lu Z, Ma C, Guo T, Xie S, Twamley EW, Jin H, Zhao J. Effectiveness of maintenance treatments with atypical and typical antipsychotics in stable schizophrenia with early stage: 1-year naturalistic study. Psychopharmacology (Berl). 2011 Aug;216(4):475-84. doi: 10.1007/s00213-011-2242-3. Epub 2011 Mar 3.
Guo X, Zhai J, Liu Z, Fang M, Wang B, Wang C, Hu B, Sun X, Lv L, Lu Z, Ma C, He X, Guo T, Xie S, Wu R, Xue Z, Chen J, Twamley EW, Jin H, Zhao J. Effect of antipsychotic medication alone vs combined with psychosocial intervention on outcomes of early-stage schizophrenia: A randomized, 1-year study. Arch Gen Psychiatry. 2010 Sep;67(9):895-904. doi: 10.1001/archgenpsychiatry.2010.105.
Other Identifiers
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2004BA720A22
Identifier Type: -
Identifier Source: org_study_id