Title
Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia
Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia:One-Year Follow up.
Phase
Phase 4Lead Sponsor
Central South UniversityStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
SchizophreniaIntervention/Treatment
chlorpromazine clozapine olanzapine risperidone aripiprazole quetiapine sulpiride ...Study Participants
1400Antipsychotic 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.
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.
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.
the psychosocial interventions include psychoeducaiton, family intervention, skill training, and cognitive-behavioral therapy.
the comparator arm will only receive one of the seven antipsychotic
the experimental group will receive one of the seven study drugs combination with psychosocial intervention
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