Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia - Tabular View

Tracking Information
First Received Date ^ICMJE	April 3, 2008
Last Updated Date	April 7, 2008
Start Date ^ICMJE	February 2005
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 7, 2008)	the time to discontinued treatment and the rate of relapse/rehospitalization [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00654576 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 7, 2008)	clinical psychopathology, side effect, compliance, social function, neurocognitive function, quality of life, family/career burden, cost analysis. [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia
Official Title ^ICMJE	Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia:One-Year Follow up.
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.
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Condition ^ICMJE	Schizophrenia
Intervention ^ICMJE	Drug: Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole Behavioral: psychosocial intervention
Study Arms / Comparison Groups	Active Comparator: the comparator arm will only receive one of the seven antipsychotic Experimental: the experimental group will receive one of the seven study drugs combination with psychosocial intervention
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	1400
Completion Date	December 2007
Primary Completion Date	December 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	16 Years to 50 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	China

Administrative Information
NCT ID ^ICMJE	NCT00654576
Responsible Party
Study ID Numbers ^ICMJE	2004BA720A22
Study Sponsor ^ICMJE	Central South University
Collaborators ^ICMJE	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
Investigators ^ICMJE
Information Provided By	Central South University
Verification Date	April 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP