Standard Comprehensive Intervention to Treat First-episode Schizophrenia
Recruitment status was Recruiting
Tracking Information | |||||
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First Received Date ICMJE | January 26, 2010 | ||||
Last Updated Date | January 26, 2010 | ||||
Start Date ICMJE | September 2008 | ||||
Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
the time the patients remain stable [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
Scoring of PANSS and PSP [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
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. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Schizophrenia | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 600 | ||||
Completion Date | |||||
Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 16 Years to 45 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE |
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Location Countries ICMJE | China | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01057849 | ||||
Other Study ID Numbers ICMJE | 2007BAI17B04 | ||||
Has Data Monitoring Committee | Yes | ||||
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 |
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Information Provided By | Peking University | ||||
Verification Date | September 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |