Standard Comprehensive Intervention to Treat First-episode Schizophrenia

January 26, 2010 updated by: Peking University

Sequenced Atypical Antipsychotics Therapy With Intensive or Basic Psychosocial Intervention for First-episode Schizophrenia: An Effectiveness Study

Schizophrenia is not a curable but a treatable disease by antipsychotics. Kinds of atypical antipsychotics are widely used since 1990s' in China. Although their efficacy for acute phase are all better than typicals, individulized regimen of them for first-episode schizophrenia and their effectiveness in real naturalistic clinical settings still remain unclear. And those patients also need more comprehensive intervention such as psychosocial programs to improve their function. This protocol is to conduct a study in several sites of China to investigate the effectiveness of comprehensive intervention combining sequenced atypical antipsychotic therapy and intensive psychosocial intervention for first-episode schizophrenic patients. In addition, this protocol also aims at collecting such information as molecular genetics, neurochemical test, neucognitive performance and neuroimaging for outcome analysis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

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
    • Beijing
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Beijing Anding Hospital
        • Contact:
        • Principal Investigator:
          • Chuanyue Wang, M.D.
        • Sub-Investigator:
          • Fuchun Zhou, M.D.
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Beijing HuiLongGuan Hospital
        • Contact:
        • Principal Investigator:
          • Fude Yang, M.D.
        • Sub-Investigator:
          • Yunlong Tan, M.D.
      • Haidian District, Beijing, China, 100191
        • Recruiting
        • Peking University Institute of Mental Health
        • Contact:
        • Principal Investigator:
          • Yanbo Yuan, M.D.
        • Sub-Investigator:
          • Qi Liu, M.D.
    • Hunan
      • Changsha, Hunan, China, 410000
        • Recruiting
        • Zhongnan University Xiangya Second Hospital
        • Contact:
        • Principal Investigator:
          • Jingping Zhao, M.D.
        • Sub-Investigator:
          • Lehua Li, M.D.
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Mental Health Center
        • Contact:
        • Principal Investigator:
          • Zheng Lu, M.D.
        • Sub-Investigator:
          • Jianhua Sheng, M.D.
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • Sichuan University Huaxi Hospital
        • Contact:
        • Principal Investigator:
          • Hong Deng, M.D.
        • Sub-Investigator:
          • Shanming Liu, M.D.

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

16 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • schizophrenic patients diagnosed with DSM-IV criteria by SCID-I.
  • age between 16-45 years old
  • with disease course less than 3 years and during their first episode
  • without receiving systematic antipsychotic treatment less than 1 month

Exclusion Criteria:

  • organic disease or unstable physical diseases.
  • brain trauma with loss of consciousness more than 1 hour
  • current substance misuse (in 3 months) or any substance dependence.
  • pregnant women.
  • patients with severe suicidal imaginations or behavior.
  • mental retardation
  • contradict to the study drugs

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Risperidone, Intensive
risperidone and intensive psychosocial intervention
Drug: risperidone
3-6 mg per day
Active Comparator: risperidone, basic
risperidone and basic psychosocial support
Drug: risperidone
3-6 mg per day
Experimental: olanzapine, intensive
olanzapine and intensive psychosocial intervention
Drug: olanzapine
5-20 mg per day
Active Comparator: olanzapine, basic
olanzapine and basic psychosocial support
Drug: olanzapine
5-20 mg per day
Experimental: aripiprazole, intensive
aripiprazole and intensive psychosocial intervention
Drug: Aripiprazole
10-30 mg per day
Active Comparator: aripiprazole, basiv
aripiprazole and basic psychosocial support
Drug: Aripiprazole
10-30 mg per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the time the patients remain stable
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Scoring of PANSS and PSP
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Peking University

Collaborators

Ministry of Science and Technology of the People´s Republic of China

Investigators

  • Principal Investigator: Xin Yu, M.D., Peking University Institute of Mental Health

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

September 1, 2008

Primary Completion (Anticipated)

March 1, 2011

Study Registration Dates

First Submitted

January 26, 2010

First Submitted That Met QC Criteria

January 26, 2010

First Posted (Estimate)

January 27, 2010

Study Record Updates

Last Update Posted (Estimate)

January 27, 2010

Last Update Submitted That Met QC Criteria

January 26, 2010

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007BAI17B04

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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