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

Phase 4

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole; Behavioral: psychosocial intervention

• Registration Number: NCT00654576
• Lead Sponsor: Central South University

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.

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 Timeline

• Study Start: 2005-02
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2008-04
• Study First Submitted: 2008-04-03
• Study First Submitted QC: 2008-04-07
• Last Update Submitted: 2008-04-07
• Study First Posted: 2008-04-08
• Last Update Posted: 2008-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole	the comparator arm will only receive one of the seven antipsychotic
2	psychosocial intervention	the experimental group will receive one of the seven study drugs combination with psychosocial intervention

Primary Outcome Measures

Name	Time	Method
the time to discontinued treatment and the rate of relapse/rehospitalization

Secondary Outcome Measures

Name	Time	Method
clinical psychopathology, side effect, compliance, social function, neurocognitive function, quality of life, family/career burden, cost analysis.

Trial Locations

Locations (1)

Institute of Mental Health of The Second Xiangya Hospital, Central South University; 🇨🇳 Changsha, Hunan, China