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

Central South University

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Behavioral: psychosocial intervention; Drug: Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole

Study type: Interventional

Funder types: Other

Identifiers

NCT00654576

2004BA720A22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,400 estimated patients

Sex: All

Ages: 16 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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1,400 participants in 2 patient groups

1

Active Comparator group

Description:

the comparator arm will only receive one of the seven antipsychotic

Treatment:

Drug: Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole

2

Experimental group

Description:

the experimental group will receive one of the seven study drugs combination with psychosocial intervention

Treatment:

Behavioral: psychosocial intervention