Standard Comprehensive Intervention to Treat First-episode Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Peking University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ministry of Science and Technology of the People´s Republic of China
Information provided by:
Peking University
ClinicalTrials.gov Identifier:
NCT01057849
First received: January 26, 2010
Last updated: NA
Last verified: September 2008
History: No changes posted

January 26, 2010
January 26, 2010
September 2008
March 2011   (final data collection date for primary outcome measure)
the time the patients remain stable [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Scoring of PANSS and PSP [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
 
 
 
Standard Comprehensive Intervention to Treat First-episode Schizophrenia
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.

 
Interventional
 
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Schizophrenia
  • Drug: risperidone
    3-6 mg per day
  • Drug: olanzapine
    5-20 mg per day
  • Drug: Aripiprazole
    10-30 mg per day
  • 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
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
 
March 2011   (final data collection date for primary outcome measure)

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
Both
16 Years to 45 Years
Yes
Contact: Yanbo Yuan, M.D. +8613910821507 yuanyb@gmail.com
China
 
NCT01057849
2007BAI17B04
Yes
Xin Yu, Peking University Institute of Mental Health
Peking University
Ministry of Science and Technology of the People´s Republic of China
Principal Investigator: Xin Yu, M.D. Peking University Institute of Mental Health
Peking University
September 2008

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