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

Sponsor

Central South University (Other)

Overall Status

Completed

CT.gov ID

NCT00654576

Collaborator

Shanghai Mental Health Center (Other), Sichuan University (Other), Capital Medical University (Other), Nanjing Medical University (Other), Jiangxi Mental Hospital (Other), Hunan Mental Hospital (Other), Guangzhou Mental Hospital (Other), Chongqing Metal Institute (Other), Henan Mental Hospital (Other)

1,400

Enrollment

Location

Arms

33.9

Duration (Months)

41.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole Behavioral: psychosocial intervention	Phase 4

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 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 Design

Study Type:

Interventional

Anticipated Enrollment :

1400 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2005

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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.
Experimental: 2 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.

Arm

Intervention/Treatment

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.

Experimental: 2

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.

Outcome Measures

Primary Outcome Measures

the time to discontinued treatment and the rate of relapse/rehospitalization []

Secondary Outcome Measures

clinical psychopathology, side effect, compliance, social function, neurocognitive function, quality of life, family/career burden, cost analysis. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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