Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia
Information source: Central South University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole (Drug); psychosocial intervention (Behavioral)
Phase: Phase 4
Status: Completed
Sponsored by: Central South University
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.
Clinical Details
Official title: Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia:One-Year Follow up.
Study design: Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Primary outcome: the time to discontinued treatment and the rate of relapse/rehospitalization
Secondary outcome: clinical psychopathology, side effect, compliance, social function, neurocognitive function, quality of life, family/career burden, cost analysis.
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.
Eligibility
Minimum age: 16 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
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 and Contacts
Institute of Mental Health of The Second Xiangya Hospital, Central South University, changsha, Hunan 410011, China
Additional Information
Starting date: February 2005
Ending date: December 2007
Last updated: April 7, 2008
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