Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia

Study Overview
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Brief Summary
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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 hypothesize that there will be significant difference in the overall effectiveness between antipsychotic and antipsychotic combination with psychosocial intervention.

Detailed Description
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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.

Official Title
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Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia:One-Year Follow up.

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole
* Behavioral: psychosocial intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>the comparator arm will only receive one of the seven antipsychotic | Drug: Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole<br>* 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.<br>|
| Experimental: 2<br>the experimental group will receive one of the seven study drugs combination with psychosocial intervention | Behavioral: psychosocial intervention<br>* the psychosocial interventions include psychoeducaiton, family intervention, skill training, and cognitive-behavioral therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time to discontinued treatment and the rate of relapse/rehospitalization |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical psychopathology, side effect, compliance, social function, neurocognitive function, quality of life, family/career burden, cost analysis. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, antipsychotic, outcome, psychosocial intervention