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Sponsors and Collaborators: |
Seoul National University Hospital Korea Otsuka Pharmaceutical Co.,Ltd. |
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Information provided by: | Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT00328367 |
The purpose of this study is to determine whether aripiprazole augmentation is safe and effective in the treatment of clozapine-treated patients with refractory schizophrenia.
Condition | Intervention | Phase |
---|---|---|
Schizophrenia |
Drug: aripiprazole Drug: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind Randomized Placebo Controlled Study of Aripiprazole Augmentation for Clozapine-Treated Patients With Refractory Schizophrenia |
Enrollment: | 61 |
Study Start Date: | December 2005 |
Study Completion Date: | February 2008 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
clozapine plus aripiprazole
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Drug: aripiprazole
aripiprazole augmentation of clozapine
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B: Placebo Comparator
clozapine plus placebo
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Drug: placebo
placebo
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Clozapine is renowned for its efficacy in treating schizophrenia refractory to typical or atypical antipsychotics. Though the effectiveness of clozapine has been established, a considerable number of patients with schizophrenia are partially responsive or unresponsive to clozapine. In addition, long-term use of clozapine is associated with the development of obsessive-compulsive symptoms and metabolic syndrome. In order to overcome these short-comings and to increase efficacy, aripiprazole augmentation was implemented. Quantitative electroencephalogram will be used to monitor the occurrence of abnormal findings and to analyze the changes in electroencephalographic pattern with linear and non-linear methodology.
Comparisons: Design of double-blind randomized placebo controlled study of patients at Refractory Schizophrenia Clinique in Department of Neuropsychiatry at Seoul National University Hospital.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Korea, Republic of | |
Seoul National University Hospital | |
Seoul, Korea, Republic of, 110-744 |
Principal Investigator: | Yong Sik Kim, MD, PhD | Seoul National University Hospital |
Responsible Party: | Seoul National University Hospital ( Yong Sik Kim/Professor ) |
Study ID Numbers: | KYS-2006-05209 |
Study First Received: | May 17, 2006 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00328367 |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
schizophrenia aripiprazole clozapine |
Schizophrenia Mental Disorders Clozapine Psychotic Disorders |
Aripiprazole Serotonin Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents |
Pharmacologic Actions GABA Antagonists Serotonin Antagonists Serotonin Agents Therapeutic Uses GABA Agents Central Nervous System Agents |