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Standard Comprehensive Intervention to Treat First-episode Schizophrenia

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
risperidone
olanzapine
Aripiprazole
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, first episode, atypical antipsychotics, psychosocial intervention, outcome, effectiveness

Eligibility Criteria

16 Years - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Beijing Anding HospitalRecruiting
  • Beijing Huilongguan HospitalRecruiting
  • Peking University Institute of Mental HealthRecruiting
  • Zhongnan University Xiangya Second HospitalRecruiting
  • Shanghai Mental Health CenterRecruiting
  • Sichuan University Huaxi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Risperidone, Intensive

risperidone, basic

olanzapine, intensive

olanzapine, basic

aripiprazole, intensive

aripiprazole, basiv

Arm Description

risperidone and intensive psychosocial intervention

risperidone and basic psychosocial support

olanzapine and intensive psychosocial intervention

olanzapine and basic psychosocial support

aripiprazole and intensive psychosocial intervention

aripiprazole and basic psychosocial support

Outcomes

Primary Outcome Measures

the time the patients remain stable

Secondary Outcome Measures

Scoring of PANSS and PSP

Full Information

First Posted
January 26, 2010
Last Updated
January 26, 2010
Sponsor
Peking University
Collaborators
Ministry of Science and Technology of the People´s Republic of China
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1. Study Identification

Unique Protocol Identification Number
NCT01057849
Brief Title
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

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Peking University
Collaborators
Ministry of Science and Technology of the People´s Republic of China

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, first episode, atypical antipsychotics, psychosocial intervention, outcome, effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Risperidone, Intensive
Arm Type
Experimental
Arm Description
risperidone and intensive psychosocial intervention
Arm Title
risperidone, basic
Arm Type
Active Comparator
Arm Description
risperidone and basic psychosocial support
Arm Title
olanzapine, intensive
Arm Type
Experimental
Arm Description
olanzapine and intensive psychosocial intervention
Arm Title
olanzapine, basic
Arm Type
Active Comparator
Arm Description
olanzapine and basic psychosocial support
Arm Title
aripiprazole, intensive
Arm Type
Experimental
Arm Description
aripiprazole and intensive psychosocial intervention
Arm Title
aripiprazole, basiv
Arm Type
Active Comparator
Arm Description
aripiprazole and basic psychosocial support
Intervention Type
Drug
Intervention Name(s)
risperidone
Intervention Description
3-6 mg per day
Intervention Type
Drug
Intervention Name(s)
olanzapine
Intervention Description
5-20 mg per day
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Intervention Description
10-30 mg per day
Primary Outcome Measure Information:
Title
the time the patients remain stable
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Scoring of PANSS and PSP
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanbo Yuan, M.D.
Phone
+8613910821507
Email
yuanyb@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Yu, M.D.
Organizational Affiliation
Peking University Institute of Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anding Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Zhou
Email
pretty_zhouyan@126.com
First Name & Middle Initial & Last Name & Degree
Chuanyue Wang, M.D.
First Name & Middle Initial & Last Name & Degree
Fuchun Zhou, M.D.
Facility Name
Beijing Huilongguan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Song Chen, M.D.
Email
asongsi@gmail.com
First Name & Middle Initial & Last Name & Degree
Fude Yang, M.D.
First Name & Middle Initial & Last Name & Degree
Yunlong Tan, M.D.
Facility Name
Peking University Institute of Mental Health
City
Haidian District
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanbo Yuan, M.D.
Phone
+86-10-82806157
Email
yuanyb@gmail.com
First Name & Middle Initial & Last Name & Degree
Yanbo Yuan, M.D.
First Name & Middle Initial & Last Name & Degree
Qi Liu, M.D.
Facility Name
Zhongnan University Xiangya Second Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maorong Hu, M.D.
Email
maron13@126.com
First Name & Middle Initial & Last Name & Degree
Jingping Zhao, M.D.
First Name & Middle Initial & Last Name & Degree
Lehua Li, M.D.
Facility Name
Shanghai Mental Health Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu, M.D.
Email
lnmilk-1982@126.com
First Name & Middle Initial & Last Name & Degree
Zheng Lu, M.D.
First Name & Middle Initial & Last Name & Degree
Jianhua Sheng, M.D.
Facility Name
Sichuan University Huaxi Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shanming Liu, M.D.
Email
lciauo@sina.com
First Name & Middle Initial & Last Name & Degree
Hong Deng, M.D.
First Name & Middle Initial & Last Name & Degree
Shanming Liu, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
32636771
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.
Results Reference
derived
PubMed Identifier
25482837
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.
Results Reference
derived

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Standard Comprehensive Intervention to Treat First-episode Schizophrenia

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