Standard Comprehensive Intervention to Treat First-episode Schizophrenia

Schizophrenia Clinical Trial

Official title:

Sequenced Atypical Antipsychotics Therapy With Intensive or Basic Psychosocial Intervention for First-episode Schizophrenia: An Effectiveness Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01057849
• Other study ID #: 2007BAI17B04
• Status: Recruiting
• Phase: N/A
• First received: January 26, 2010
• Last updated: January 26, 2010
• Start date: September 2008

Study information

• Verified date: September 2008
• Source: Peking University
• Contact: Yanbo Yuan, M.D.
• Phone: +8613910821507
• Email: yuanyb[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• risperidone
3-6 mg per day
• olanzapine
5-20 mg per day
• Aripiprazole
10-30 mg per day

Locations

Country	Name	City	State
China	Beijing Anding Hospital	Beijing	Beijing
China	Beijing Huilongguan Hospital	Beijing	Beijing
China	Zhongnan University Xiangya Second Hospital	Changsha	Hunan
China	Sichuan University Huaxi Hospital	Chengdu	Sichuan
China	Peking University Institute of Mental Health	Haidian District	Beijing
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Peking University	Ministry of Science and Technology of the People´s Republic of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the time the patients remain stable		1 year	No
Secondary	Scoring of PANSS and PSP		1 year	No