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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole
psychosocial intervention
Sponsored by
Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, antipsychotic, outcome, psychosocial intervention

Eligibility Criteria

16 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Mental Health of The Second Xiangya Hospital, Central South University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

the comparator arm will only receive one of the seven antipsychotic

the experimental group will receive one of the seven study drugs combination with psychosocial intervention

Outcomes

Primary Outcome Measures

the time to discontinued treatment and the rate of relapse/rehospitalization

Secondary Outcome Measures

clinical psychopathology, side effect, compliance, social function, neurocognitive function, quality of life, family/career burden, cost analysis.

Full Information

First Posted
April 3, 2008
Last Updated
April 7, 2008
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
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1. Study Identification

Unique Protocol Identification Number
NCT00654576
Brief Title
Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia
Acronym
ACPIOS
Official Title
Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia:One-Year Follow up.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, antipsychotic, outcome, psychosocial intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
the comparator arm will only receive one of the seven antipsychotic
Arm Title
2
Arm Type
Experimental
Arm Description
the experimental group will receive one of the seven study drugs combination with psychosocial intervention
Intervention Type
Drug
Intervention Name(s)
Chlorpromazine, Sulpiride, Clozapine, Olanzapine, Risperidone, Quetiapine, Aripitrazole
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
psychosocial intervention
Intervention Description
the psychosocial interventions include psychoeducaiton, family intervention, skill training, and cognitive-behavioral therapy.
Primary Outcome Measure Information:
Title
the time to discontinued treatment and the rate of relapse/rehospitalization
Secondary Outcome Measure Information:
Title
clinical psychopathology, side effect, compliance, social function, neurocognitive function, quality of life, family/career burden, cost analysis.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Institute of Mental Health of The Second Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25064681
Citation
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.
Results Reference
derived
PubMed Identifier
21369751
Citation
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.
Results Reference
derived
PubMed Identifier
20819983
Citation
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.
Results Reference
derived

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Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia

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