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

Central South University1,400 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,400

Conditions

Schizophrenia

Interventions

Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, AripitrazoleDRUG

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.

psychosocial interventionBEHAVIORAL

the psychosocial interventions include psychoeducaiton, family intervention, skill training, and cognitive-behavioral therapy.

Eligibility

Sex: ALLMin age: 16 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Institute of Mental Health of The Second Xiangya Hospital, Central South University

Changsha, Hunan, China

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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