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Home > Clinical Trials > A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept, Phase 2 Study to Evaluate the Efficacy and Safety of Once a Day, TAK-375SL 0.1, 0.4, and 0.8 mg as an Adjunctive Therapy to Treatment-as-Usual in the Maintenance Treatment of Bipolar I Disorder in Adults.
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A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept, Phase 2 Study to Evaluate the Efficacy and Safety of Once a Day, TAK-375SL 0.1, 0.4, and 0.8 mg as an Adjunctive Therapy to Treatment-as-Usual in the Maintenance Treatment of Bipolar I Disorder in Adults.

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The purpose of this study is to determine if a new formulation of ramelteon (TAK-375SL) is effective in decreasing the symptoms of depression associated with bipolar I disorder so the study evaluates using an additional drug to your current medication to control depression in bipolar individuals. 18-75 years old and your participation will last approximately 11 months and will include about 14 study visits to the study center. Compensation will be upto $455.00.

For more information, contact Nabila Lateef at 919-684-9701.


(REF# Pro00034212)
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Updated: Dec. 5, 2012
Published: Dec. 5, 2012
URL: http://www.dukehealth.org/clinicaltrials/20121205140857701