- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00654576
Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia (ACPIOS)
Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia:One-Year Follow up.
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
Hunan
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Changsha, Hunan, China, 410011
- Institute of Mental Health of The Second Xiangya Hospital, Central South University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
the comparator arm will only receive one of the seven antipsychotic
|
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
|
the psychosocial interventions include psychoeducaiton, family intervention, skill training, and cognitive-behavioral therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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the time to discontinued treatment and the rate of relapse/rehospitalization
|
Secondary Outcome Measures
Outcome Measure |
---|
clinical psychopathology, side effect, compliance, social function, neurocognitive function, quality of life, family/career burden, cost analysis.
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- GABA Agents
- Antidepressive Agents, Second-Generation
- GABA Antagonists
- Olanzapine
- Quetiapine Fumarate
- Risperidone
- Clozapine
- Chlorpromazine
- Sulpiride
Other Study ID Numbers
- 2004BA720A22
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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