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Standard Comprehensive Intervention to Treat First-episode Schizophrenia

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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   (Child, Adult)
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

Locations
China, Beijing
Beijing Anding Hospital
Beijing, Beijing, China, 100000
Beijing Huilongguan Hospital
Beijing, Beijing, China, 100000
Peking University Institute of Mental Health
Haidian District, Beijing, China, 100191
China, Hunan
Zhongnan University Xiangya Second Hospital
Changsha, Hunan, China, 410000
China, Shanghai
Shanghai Mental Health Center
Shanghai, Shanghai, China, 200030
China, Sichuan
Sichuan University Huaxi Hospital
Chengdu, Sichuan, China, 610000
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Aripiprazole
Olanzapine
Risperidone
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Serotonin Antagonists
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on December 08, 2016