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
Recruitment status was Recruiting
Sponsor:
Peking University
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
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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
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 Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on June 17, 2013