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
Ministry of Science and Technology of the People´s Republic of China
Information provided by:
Peking University Identifier:
First received: January 26, 2010
Last updated: NA
Last verified: September 2008
History: No changes posted
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
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


Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Both
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
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 identifier: NCT01057849

Contact: Yanbo Yuan, M.D. +8613910821507

China, Beijing
Beijing Anding Hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Yan Zhou   
Principal Investigator: Chuanyue Wang, M.D.         
Sub-Investigator: Fuchun Zhou, M.D.         
Beijing Huilongguan Hospital Recruiting
Beijing, Beijing, China, 100000
Contact: Song Chen, M.D.   
Principal Investigator: Fude Yang, M.D.         
Sub-Investigator: Yunlong Tan, M.D.         
Peking University Institute of Mental Health Recruiting
Haidian District, Beijing, China, 100191
Contact: Yanbo Yuan, M.D.    +86-10-82806157   
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.   
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.   
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.   
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
Principal Investigator: Xin Yu, M.D. Peking University Institute of Mental Health
  More Information

No publications provided by Peking University

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Xin Yu, Peking University Institute of Mental Health 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:
first episode
atypical antipsychotics
psychosocial intervention

Additional relevant MeSH terms:
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents processed this record on November 25, 2015