Clinical trial NCT01057849: Standard Comprehensive Intervention to Treat First-episode Schizophrenia
Official title: Sequenced Atypical Antipsychotics Therapy With Intensive or Basic Psychosocial Intervention for First-episode Schizophrenia: An Effectiveness Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
first episode
atypical antipsychotics
psychosocial intervention
outcome
effectiveness
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2010-01-27
Enrollment: 600
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: the time the patients remain stable
timeFrame: 1 year
Secondary outcomes:
measure: Scoring of PANSS and PSP
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anding Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Huilongguan Hospital
state: Beijing
city: Haidian District
country: China
facility: Peking University Institute of Mental Health
state: Beijing
city: Changsha
country: China
facility: Zhongnan University Xiangya Second Hospital
state: Hunan
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
city: Chengdu
country: China
facility: Sichuan University Huaxi Hospital
state: Sichuan
Study officials:
affiliation: Peking University Institute of Mental Health
name: Xin Yu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheng 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.
citation: 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.