Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia (ACPIOS)

This study has been completed.
Sponsor:
Collaborators:
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
Information provided by:
Central South University
ClinicalTrials.gov Identifier:
NCT00654576
First received: April 3, 2008
Last updated: April 7, 2008
Last verified: April 2008

April 3, 2008
April 7, 2008
February 2005
December 2007   (final data collection date for primary outcome measure)
the time to discontinued treatment and the rate of relapse/rehospitalization [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00654576 on ClinicalTrials.gov Archive Site
clinical psychopathology, side effect, compliance, social function, neurocognitive function, quality of life, family/career burden, cost analysis. [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Schizophrenia
  • Drug: Chlorpromazine, 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.
  • Behavioral: psychosocial intervention
    the psychosocial interventions include psychoeducaiton, family intervention, skill training, and cognitive-behavioral therapy.
  • Active Comparator: 1
    the comparator arm will only receive one of the seven antipsychotic
    Intervention: Drug: Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole
  • Experimental: 2
    the experimental group will receive one of the seven study drugs combination with psychosocial intervention
    Intervention: Behavioral: psychosocial intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1400
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
16 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00654576
2004BA720A22
Yes
Not Provided
Central South University
  • 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
Not Provided
Central South University
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP