Standard Comprehensive Intervention to Treat First-episode Schizophrenia

Not Applicable

• Conditions: Schizophrenia
• Interventions: Drug: risperidone; Drug: Aripiprazole; Drug: olanzapine

• Registration Number: NCT01057849
• Lead Sponsor: Peking University

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 available

Study Timeline

• Status Verified: 2008-09
• Study Start: 2008-09
• Study First Submitted: 2010-01-26
• Study First Submitted QC: 2010-01-26
• Last Update Submitted: 2010-01-26
• Study First Posted: 2010-01-27
• Last Update Posted: 2010-01-27
• Primary Completion: 2011-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Risperidone, Intensive	risperidone	risperidone and intensive psychosocial intervention
aripiprazole, intensive	Aripiprazole	aripiprazole and intensive psychosocial intervention
olanzapine, basic	olanzapine	olanzapine and basic psychosocial support
risperidone, basic	risperidone	risperidone and basic psychosocial support
olanzapine, intensive	olanzapine	olanzapine and intensive psychosocial intervention
aripiprazole, basiv	Aripiprazole	aripiprazole and basic psychosocial support

Primary Outcome Measures

Name	Time	Method
the time the patients remain stable	1 year

Secondary Outcome Measures

Name	Time	Method
Scoring of PANSS and PSP	1 year

Trial Locations

Locations (6)

Beijing Anding Hospital; 🇨🇳 Beijing, Beijing, China

Zhongnan University Xiangya Second Hospital; 🇨🇳 Changsha, Hunan, China

Beijing Huilongguan Hospital; 🇨🇳 Beijing, Beijing, China

Sichuan University Huaxi Hospital; 🇨🇳 Chengdu, Sichuan, China

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China

Peking University Institute of Mental Health; 🇨🇳 Haidian District, Beijing, China