Last updated on July 2016

A Phase III Study of SM-13496 in Patients With Bipolar I Depression.


Brief description of study

The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with Bipolar I Depression.

Detailed Study Description

The primary objective is to compare the efficacy of SM-13496 (20-60 or 80-120 mg/day) monotherapy with that of placebo in patients with depressive symptoms associated with bipolar I disorder by assessing the change from baseline in the MADRS total score at Week 6.

Clinical Study Identifier: NCT01986101

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Principal investigator

Japan 68 sites
Tokyo, Japan
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Sumitomo Dainippon Pharma Co., Ltd.

Lithuania 3 sites
Kaunas, Lithuania
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Sumitomo Dainippon Pharma Co., Ltd.

Malaysia 5 sites
Kuala Lumpur, Malaysia
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Principal Investigator

Philippines 5 sites
Manila, Philippines
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Sumitomo Dainippon Pharma Co., Ltd.

Russia 19 sites
Moscow, Russian Federation
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Sumitomo Dainippon Pharma Co., Ltd.

Slovakia 5 sites
Zilina, Slovakia
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