Standard Comprehensive Intervention to Treat First-episode Schizophrenia

Sponsor

Peking University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01057849

Collaborator

Ministry of Science and Technology of the People´s Republic of China (Other)

600

Enrollment

Locations

Arms

100

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: risperidone Drug: olanzapine Drug: Aripiprazole	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2008

Anticipated Primary Completion Date :

Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Risperidone, Intensive risperidone and intensive psychosocial intervention	Drug: risperidone 3-6 mg per day
Active Comparator: risperidone, basic risperidone and basic psychosocial support	Drug: risperidone 3-6 mg per day
Experimental: olanzapine, intensive olanzapine and intensive psychosocial intervention	Drug: olanzapine 5-20 mg per day
Active Comparator: olanzapine, basic olanzapine and basic psychosocial support	Drug: olanzapine 5-20 mg per day
Experimental: aripiprazole, intensive aripiprazole and intensive psychosocial intervention	Drug: Aripiprazole 10-30 mg per day
Active Comparator: aripiprazole, basiv aripiprazole and basic psychosocial support	Drug: Aripiprazole 10-30 mg per day

Outcome Measures

Primary Outcome Measures

the time the patients remain stable [1 year]

Secondary Outcome Measures

Scoring of PANSS and PSP [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Anding Hospital	Beijing	Beijing	China	100000
2	Beijing Huilongguan Hospital	Beijing	Beijing	China	100000
3	Peking University Institute of Mental Health	Haidian District	Beijing	China	100191
4	Zhongnan University Xiangya Second Hospital	Changsha	Hunan	China	410000
5	Shanghai Mental Health Center	Shanghai	Shanghai	China	200030
6	Sichuan University Huaxi Hospital	Chengdu	Sichuan	China	610000