Standard Comprehensive Intervention to Treat First-episode Schizophrenia

NCT ID: NCT01057849

Last Updated: 2010-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Brief Summary

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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

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Risperidone, Intensive

risperidone and intensive psychosocial intervention

Group Type EXPERIMENTAL

risperidone

Intervention Type DRUG

3-6 mg per day

risperidone, basic

risperidone and basic psychosocial support

Group Type ACTIVE_COMPARATOR

risperidone

Intervention Type DRUG

3-6 mg per day

olanzapine, intensive

olanzapine and intensive psychosocial intervention

Group Type EXPERIMENTAL

olanzapine

Intervention Type DRUG

5-20 mg per day

olanzapine, basic

olanzapine and basic psychosocial support

Group Type ACTIVE_COMPARATOR

olanzapine

Intervention Type DRUG

5-20 mg per day

aripiprazole, intensive

aripiprazole and intensive psychosocial intervention

Group Type EXPERIMENTAL

Aripiprazole

Intervention Type DRUG

10-30 mg per day

aripiprazole, basiv

aripiprazole and basic psychosocial support

Group Type ACTIVE_COMPARATOR

Aripiprazole

Intervention Type DRUG

10-30 mg per day

Interventions

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risperidone

3-6 mg per day

Intervention Type DRUG

olanzapine

5-20 mg per day

Intervention Type DRUG

Aripiprazole

10-30 mg per day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Science and Technology of the People“s Republic of China

OTHER_GOV

Sponsor Role collaborator

Peking University

OTHER

Sponsor Role lead

Responsible Party

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Peking University Institute of Mental Health

Principal Investigators

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Xin Yu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking University Institute of Mental Health

Locations

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Beijing Anding Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Huilongguan Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Peking University Institute of Mental Health

Haidian District, Beijing Municipality, China

Site Status RECRUITING

Zhongnan University Xiangya Second Hospital

Changsha, Hunan, China

Site Status RECRUITING

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Sichuan University Huaxi Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yanbo Yuan, M.D.

Role: CONTACT

+8613910821507

Facility Contacts

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Yan Zhou

Role: primary

Song Chen, M.D.

Role: primary

Yanbo Yuan, M.D.

Role: primary

+86-10-82806157

Maorong Hu, M.D.

Role: primary

Liu, M.D.

Role: primary

Shanming Liu, M.D.

Role: primary

References

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Dai 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.

Reference Type DERIVED
PMID: 38053101 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32636771 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25482837 (View on PubMed)

Other Identifiers

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2007BAI17B04

Identifier Type: -

Identifier Source: org_study_id

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