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

Sponsor:	Central South University
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

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole Behavioral: psychosocial intervention	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia:One-Year Follow up.

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Chlorpromazine Chlorpromazine hydrochloride Sulpiride Risperidone Quetiapine Quetiapine fumarate Olanzapine Clozapine

U.S. FDA Resources

Further study details as provided by Central South University:

Primary Outcome Measures:

the time to discontinued treatment and the rate of relapse/rehospitalization [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

clinical psychopathology, side effect, compliance, social function, neurocognitive function, quality of life, family/career burden, cost analysis. [ Designated as safety issue: Yes ]

Estimated Enrollment:	1400
Study Start Date:	February 2005
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 the comparator arm will only receive one of the seven antipsychotic	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.
Experimental: 2 the experimental group will receive one of the seven study drugs combination with psychosocial intervention	Behavioral: psychosocial intervention the psychosocial interventions include psychoeducaiton, family intervention, skill training, and cognitive-behavioral therapy.

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

Ages Eligible for Study:	16 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654576

Locations

China, Hunan
Institute of Mental Health of The Second Xiangya Hospital, Central South University
Changsha, Hunan, China, 410011

Sponsors and Collaborators

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

More Information

No publications provided by Central South University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Mar 3.

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.

ClinicalTrials.gov Identifier:	NCT00654576 History of Changes
Other Study ID Numbers:	2004BA720A22
Study First Received:	April 3, 2008
Last Updated:	April 7, 2008
Health Authority:	China: State Food and Drug Administration

Keywords provided by Central South University:

schizophrenia
antipsychotic
outcome
psychosocial intervention

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Chlorpromazine
Olanzapine
Clozapine
Sulpiride
Antipsychotic Agents
Risperidone
Quetiapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Antagonists
Serotonin Agents
GABA Antagonists
GABA Agents
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on February 09, 2012