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
1 other identifier
interventional
600
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 26, 2010
CompletedFirst Posted
Study publicly available on registry
January 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedJanuary 27, 2010
September 1, 2008
2.5 years
January 26, 2010
January 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the time the patients remain stable
1 year
Secondary Outcomes (1)
Scoring of PANSS and PSP
1 year
Study Arms (6)
Risperidone, Intensive
EXPERIMENTALrisperidone and intensive psychosocial intervention
risperidone, basic
ACTIVE COMPARATORrisperidone and basic psychosocial support
olanzapine, intensive
EXPERIMENTALolanzapine and intensive psychosocial intervention
olanzapine, basic
ACTIVE COMPARATORolanzapine and basic psychosocial support
aripiprazole, intensive
EXPERIMENTALaripiprazole and intensive psychosocial intervention
aripiprazole, basiv
ACTIVE COMPARATORaripiprazole and basic psychosocial support
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Beijing Anding Hospital
Beijing, Beijing Municipality, 100000, China
Beijing Huilongguan Hospital
Beijing, Beijing Municipality, 100000, China
Peking University Institute of Mental Health
Haidian District, Beijing Municipality, 100191, China
Zhongnan University Xiangya Second Hospital
Changsha, Hunan, 410000, China
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030, China
Sichuan University Huaxi Hospital
Chengdu, Sichuan, 610000, China
Related Publications (4)
Yin X, Zhou T, Huang B, Lu Z, Gao T, Guo X, Hu W, Ji Y, Wang X, Zheng Y, Yu X, Pu C. Trajectory analysis of BMI increase induced by second-generation antipsychotics in first-episode schizophrenia: a secondary analysis based on CNFEST***. Schizophrenia (Heidelb). 2025 Dec 4;12(1):7. doi: 10.1038/s41537-025-00710-1.
PMID: 41345405DERIVEDDai N, Huang B, Gao T, Zheng Y, Shi C, Pu C, Yu X. Initial attitudes toward a drug predict medication adherence in first-episode patients with schizophrenia: a 1-year prospective study in China. BMC Psychiatry. 2023 Dec 5;23(1):907. doi: 10.1186/s12888-023-05419-y.
PMID: 38053101DERIVEDCheng Z, Yuan Y, Han X, Yang L, Zeng X, Yang F, Lu Z, Wang C, Deng H, Zhao J, Yu X. Which Subgroup of First-Episode Schizophrenia Patients Can Remit During the First Year of Antipsychotic Treatment? Front Psychiatry. 2020 Jun 19;11:566. doi: 10.3389/fpsyt.2020.00566. eCollection 2020.
PMID: 32636771DERIVEDHan 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.
PMID: 25482837DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xin Yu, M.D.
Peking University Institute of Mental Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 26, 2010
First Posted
January 27, 2010
Study Start
September 1, 2008
Primary Completion
March 1, 2011
Last Updated
January 27, 2010
Record last verified: 2008-09