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Sponsored by: |
Korea Otsuka Pharmaceutical Co.,Ltd. |
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Information provided by: | Korea Otsuka Pharmaceutical Co.,Ltd. |
ClinicalTrials.gov Identifier: | NCT00304655 |
The purpose of this study is to prove safety and efficacy of aripiprazole.
Condition | Intervention | Phase |
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Schizophrenia Schizoaffective Disorder |
Drug: Aripiprazole |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Multicenter, Single Group Study of Aripiprazole Efficacy and Safety in the Acute Psychosis Treatment of Schizophrenia, Schizophreniform Disorder and Schizoaffective Disorder. |
Estimated Enrollment: | 300 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | June 2006 |
This study was designed to prove safety and efficacy of aripiprazole in the treatment of acutely relapsed patients with diagnoses of schizophrenia or schizoaffective disorder in Korea and to confirm the maintenance of efficacy and safety during maintenance period and the changes in emotional factors and social functions.
After administering 15 mg/day of aripiprazole for two weeks, the test may change the dose within the range of 10 mg and 30 mg per day by clinical judgment. (Medication duration: 8 weeks (acute phase) + 18 weeks (maintenance phase)] + 26 weeks (extension phase), *total 52 weeks)
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: | Jun-Su Kwon, Prof. | Seoul National University Hospital |
Study ID Numbers: | KOP-010401 |
Study First Received: | March 17, 2006 |
Last Updated: | July 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00304655 |
Health Authority: | Korea: Institutional Review Board |
Schizophrenia Schizoaffective disorder Aripiprazole |
Schizophrenia Mental Disorders Psychotic Disorders Aripiprazole Schizophrenia and Disorders with Psychotic Features |
Tranquilizing Agents Pathologic Processes Disease Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |