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Sponsored by: |
Otsuka Pharmaceutical Co., Ltd. |
Information provided by: | Otsuka Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT00606281 |
The primary objective of this trial is to evaluate the clinical efficacy and safety of aripiprazole in comparison to placebo in patients with Bipolar I Disorder experiencing a manic or mixed episode.
Condition | Intervention | Phase |
Bipolar I Disorder |
Drug: Aripiprazole Drug: placebo |
Phase III |
MedlinePlus related topics: | Bipolar Disorder |
Drug Information available for: | Aripiprazole |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group-Comparison Trial of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode |
Estimated Enrollment: | 250 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Drug: Aripiprazole
oral, 24mg/day
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2: Placebo Comparator |
Drug: placebo
oral, 0mg(4tablets)/day
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients presenting with a clinical picture and/or history that is consistent with a DSM-IV-TR diagnosis of:
Patients who have received any of the following treatments during the screening period:
Contact: Drug Information Center OPCJ | opc_ctr@otsuka.jp |
China | |||||
Recruiting | |||||
HongKong, China | |||||
Japan | |||||
Recruiting | |||||
Hokkaido region, Japan | |||||
Recruiting | |||||
Tohoku region, Japan | |||||
Recruiting | |||||
Hokuriku region, Japan | |||||
Recruiting | |||||
Chubu region, Japan | |||||
Recruiting | |||||
Kanto region, Japan | |||||
Recruiting | |||||
Kinki region, Japan | |||||
Recruiting | |||||
Chugoku region, Japan | |||||
Recruiting | |||||
Shikoku region, Japan | |||||
Recruiting | |||||
Kyushu region, Japan | |||||
Korea, Republic of | |||||
Recruiting | |||||
Seoul, Korea, Republic of | |||||
Taiwan | |||||
Recruiting | |||||
Taipei, Taiwan |
Otsuka Pharmaceutical Co., Ltd. |
Study Director: | Katsuhisa Saito | Department of Clinical Research and Development, Division of New Product Evaluation and Development |
Responsible Party: | OPCJ ( Katsuhisa Saito ) |
Study ID Numbers: | 031-06-003 |
First Received: | January 19, 2008 |
Last Updated: | July 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00606281 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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