Schizophrenia
Conditions
Keywords
schizophrenia, antipsychotic, outcome, psychosocial intervention
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.
Interventions
DRUGChlorpromazine, 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.
BEHAVIORALpsychosocial intervention
the psychosocial interventions include psychoeducaiton, family intervention, skill training, and cognitive-behavioral therapy.
Sponsors
Shanghai Mental Health Center
Sichuan University
Capital Medical University
Nanjing Medical University
Jiangxi Mental Hospital
Hunan Mental Hospital
Guangzhou Mental Hospital
Chongqing Metal Institute
Henan Mental Hospital
Central South University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the time to discontinued treatment and the rate of relapse/rehospitalization | — |
Secondary
| Measure | Time frame |
|---|---|
| clinical psychopathology, side effect, compliance, social function, neurocognitive function, quality of life, family/career burden, cost analysis. | — |
Countries
China
Outcome results
None listed