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Sponsors and Collaborators: |
Bristol-Myers Squibb Otsuka America Pharmaceutical |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00277212 |
Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode
Condition | Intervention | Phase |
---|---|---|
Bipolar Disorder |
Drug: Lamotrigine + Aripiprazole Drug: Lamotrigine + Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Double-blind, Study of the Efficacy and Safety of Aripiprazole in Combination With Lamotrigine in the Long-term Maintenance Treatment of Patients With Bipolar I Disorder With a Recent Manic or Mixed Episode |
Enrollment: | 349 |
Study Start Date: | December 2005 |
Study Completion Date: | July 2009 |
Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A1: Experimental |
Drug: Lamotrigine + Aripiprazole
Tablets, Oral, once daily, Phase 1 (all subjects) - up to 24 weeks; Phase 2 - up to 52 weeks Lamotrigine 100-200 mg/day Aripiprazole 10-30 mg/day |
A2: Placebo Comparator |
Drug: Lamotrigine + Placebo
Tablets, Oral, once daily, Phase 2 - up to 52 weeks Lamotrigine 100-200 mg/day placebo 0 mg/day |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Health Sciences America, Llc | |
Boca Raton, Florida, United States, 33432 | |
United States, Indiana | |
Valle Vista Health System | |
Greenwood, Indiana, United States, 46143 | |
United States, Kansas | |
Clinical Trials Technology, Inc | |
Prarie Village, Kansas, United States, 66206 | |
United States, Kentucky | |
University Of Kentucky, Dept. Of Psychiatry | |
Lexington, Kentucky, United States, 40509 | |
United States, Maryland | |
Clinical Insights | |
Glen Burnie, Maryland, United States, 21061 | |
United States, New York | |
Finger Lakes Clinical Research | |
Rochester, New York, United States, 14618 | |
United States, Ohio | |
Saroj Brar Md, Inc | |
Cleveland, Ohio, United States, 44113 | |
United States, Pennsylvania | |
University Of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Washington | |
Pacific Institute Of Medical Sciences | |
Bothell, Washington, United States, 98011 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CN138-392 ST |
Study First Received: | January 13, 2006 |
Last Updated: | September 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00277212 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Bipolar I Disorder with a recent manic or mixed episode |
Tranquilizing Agents Bipolar Disorder Psychotropic Drugs Central Nervous System Depressants Calcium Channel Blockers Cardiovascular Agents Antipsychotic Agents Calcium, Dietary |
Affective Disorders, Psychotic Mental Disorders Mood Disorders Lamotrigine Psychotic Disorders Aripiprazole Anticonvulsants |
Tranquilizing Agents Disease Molecular Mechanisms of Pharmacological Action Bipolar Disorder Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Calcium Channel Blockers Cardiovascular Agents Antipsychotic Agents Pharmacologic Actions |
Membrane Transport Modulators Affective Disorders, Psychotic Pathologic Processes Mental Disorders Therapeutic Uses Mood Disorders Lamotrigine Aripiprazole Central Nervous System Agents Anticonvulsants |