Clinical trial NCT00654576: Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia
Official title: Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia:One-Year Follow up.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: schizophrenia
antipsychotic
outcome
psychosocial intervention
Lead sponsor: Central South University
Sponsor class: OTHER
Collaborators: name: Shanghai Mental Health Center
name: Sichuan University
name: Capital Medical University
name: Nanjing Medical University
name: Jiangxi Mental Hospital
name: Hunan Mental Hospital
name: Guangzhou Mental Hospital
name: Chongqing Metal Institute
name: Henan Mental Hospital
First posted: 2008-04-08
Enrollment: 1400
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: the time to discontinued treatment and the rate of relapse/rehospitalization
Secondary outcomes:
measure: clinical psychopathology, side effect, compliance, social function, neurocognitive function, quality of life, family/career burden, cost analysis.
Other outcomes:
Locations:
city: Changsha
country: China
facility: Institute of Mental Health of The Second Xiangya Hospital, Central South University
state: Hunan
Study officials:
References:
citation: Zhang Z, Zhai J, Wei Q, Qi J, Guo X, Zhao J. Cost-effectiveness analysis of psychosocial intervention for early stage schizophrenia in China: a randomized, one-year study. BMC Psychiatry. 2014 Jul 26;14:212. doi: 10.1186/s12888-014-0212-0.
citation: Guo X, Fang M, Zhai J, Wang B, Wang C, Hu B, Sun X, Lv L, Lu Z, Ma C, Guo T, Xie S, Twamley EW, Jin H, Zhao J. Effectiveness of maintenance treatments with atypical and typical antipsychotics in stable schizophrenia with early stage: 1-year naturalistic study. Psychopharmacology (Berl). 2011 Aug;216(4):475-84. doi: 10.1007/s00213-011-2242-3. Epub 2011 Mar 3.
citation: Guo X, Zhai J, Liu Z, Fang M, Wang B, Wang C, Hu B, Sun X, Lv L, Lu Z, Ma C, He X, Guo T, Xie S, Wu R, Xue Z, Chen J, Twamley EW, Jin H, Zhao J. Effect of antipsychotic medication alone vs combined with psychosocial intervention on outcomes of early-stage schizophrenia: A randomized, 1-year study. Arch Gen Psychiatry. 2010 Sep;67(9):895-904. doi: 10.1001/archgenpsychiatry.2010.105.