Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Standard Comprehensive Intervention to Treat First-episode Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01057849
Recruitment Status : Unknown
Verified September 2008 by Peking University.
Recruitment status was:  Recruiting
First Posted : January 27, 2010
Last Update Posted : January 27, 2010
Sponsor:
Collaborator:
Ministry of Science and Technology of the People´s Republic of China
Information provided by:
Peking University

Tracking Information
First Submitted Date  ICMJE January 26, 2010
First Posted Date  ICMJE January 27, 2010
Last Update Posted Date January 27, 2010
Study Start Date  ICMJE September 2008
Estimated Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2010)
the time the patients remain stable [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2010)
Scoring of PANSS and PSP [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Standard Comprehensive Intervention to Treat First-episode Schizophrenia
Official Title  ICMJE Sequenced Atypical Antipsychotics Therapy With Intensive or Basic Psychosocial Intervention for First-episode Schizophrenia: An Effectiveness Study
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: risperidone
    3-6 mg per day
  • Drug: olanzapine
    5-20 mg per day
  • Drug: Aripiprazole
    10-30 mg per day
Study Arms  ICMJE
  • Experimental: Risperidone, Intensive
    risperidone and intensive psychosocial intervention
    Intervention: Drug: risperidone
  • Active Comparator: risperidone, basic
    risperidone and basic psychosocial support
    Intervention: Drug: risperidone
  • Experimental: olanzapine, intensive
    olanzapine and intensive psychosocial intervention
    Intervention: Drug: olanzapine
  • Active Comparator: olanzapine, basic
    olanzapine and basic psychosocial support
    Intervention: Drug: olanzapine
  • Experimental: aripiprazole, intensive
    aripiprazole and intensive psychosocial intervention
    Intervention: Drug: Aripiprazole
  • Active Comparator: aripiprazole, basiv
    aripiprazole and basic psychosocial support
    Intervention: Drug: Aripiprazole
Publications * Han X, Yuan YB, Yu X, Zhao JP, Wang CY, Lu Z, Yang FD, Dong H, Wu YF, Ungvari GS, Xiang YT, Chiu HF. The Chinese First-Episode Schizophrenia Trial: background and study design. East Asian Arch Psychiatry. 2014 Dec;24(4):169-73.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 26, 2010)
600
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01057849
Other Study ID Numbers  ICMJE 2007BAI17B04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xin Yu, Peking University Institute of Mental Health
Study Sponsor  ICMJE Peking University
Collaborators  ICMJE Ministry of Science and Technology of the People´s Republic of China
Investigators  ICMJE
Principal Investigator: Xin Yu, M.D. Peking University Institute of Mental Health
PRS Account Peking University
Verification Date September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP