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

April 7, 2008 updated by: Central South University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

1400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 46 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

This is where you will find people and organizations involved with this study.

Sponsor

Central South University

Collaborators

Shanghai Mental Health Center
Capital Medical University
Nanjing Medical University
Sichuan University
Guangzhou Mental Hospital
Jiangxi Mental Hospital
Hunan Mental Hospital
Chongqing Metal Institute
Henan Mental Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

April 3, 2008

First Submitted That Met QC Criteria

April 7, 2008

First Posted (Estimate)

April 8, 2008

Study Record Updates

Last Update Posted (Estimate)

April 8, 2008

Last Update Submitted That Met QC Criteria

April 7, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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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