Standard Comprehensive Intervention to Treat First-episode Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Peking University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ministry of Science and Technology of the People´s Republic of China
Information provided by:
Peking University
ClinicalTrials.gov Identifier:
NCT01057849
First received: January 26, 2010
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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 Intervention
Schizophrenia
Drug: risperidone
Drug: olanzapine
Drug: Aripiprazole

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sequenced Atypical Antipsychotics Therapy With Intensive or Basic Psychosocial Intervention for First-episode Schizophrenia: An Effectiveness Study

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • the time the patients remain stable [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Scoring of PANSS and PSP [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: September 2008
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01057849

Contacts
Contact: Yanbo Yuan, M.D. +8613910821507 yuanyb@gmail.com

Locations
China, Beijing
Beijing Huilongguan Hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Song Chen, M.D.       asongsi@gmail.com   
Principal Investigator: Fude Yang, M.D.         
Sub-Investigator: Yunlong Tan, M.D.         
Beijing Anding Hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Yan Zhou       pretty_zhouyan@126.com   
Principal Investigator: Chuanyue Wang, M.D.         
Sub-Investigator: Fuchun Zhou, M.D.         
Peking University Institute of Mental Health Recruiting
Haidian District, Beijing, China, 100191
Contact: Yanbo Yuan, M.D.    +86-10-82806157    yuanyb@gmail.com   
Principal Investigator: Yanbo Yuan, M.D.         
Sub-Investigator: Qi Liu, M.D.         
China, Hunan
Zhongnan University Xiangya Second Hospital Recruiting
Changsha, Hunan, China, 410000
Contact: Maorong Hu, M.D.       maron13@126.com   
Principal Investigator: Jingping Zhao, M.D.         
Sub-Investigator: Lehua Li, M.D.         
China, Shanghai
Shanghai Mental Health Center Recruiting
Shanghai, Shanghai, China, 200030
Contact: Liu, M.D.       lnmilk-1982@126.com   
Principal Investigator: Zheng Lu, M.D.         
Sub-Investigator: Jianhua Sheng, M.D.         
China, Sichuan
Sichuan University Huaxi Hospital Recruiting
Chengdu, Sichuan, China, 610000
Contact: Shanming Liu, M.D.       lciauo@sina.com   
Principal Investigator: Hong Deng, M.D.         
Sub-Investigator: Shanming Liu, M.D.         
Sponsors and Collaborators
Peking University
Ministry of Science and Technology of the People´s Republic of China
Investigators
Principal Investigator: Xin Yu, M.D. Peking University Institute of Mental Health
  More Information

No publications provided

Responsible Party: Xin Yu, Peking University Institute of Mental Health
ClinicalTrials.gov Identifier: NCT01057849     History of Changes
Other Study ID Numbers: 2007BAI17B04
Study First Received: January 26, 2010
Last Updated: January 26, 2010
Health Authority: China: Ministry of Health

Keywords provided by Peking University:
schizophrenia
first episode
atypical antipsychotics
psychosocial intervention
outcome
effectiveness

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Risperidone
Olanzapine
Aripiprazole
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 27, 2014