At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 525 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
SM-13496 20mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of SM-13496 for the Treatment of Bipolar I Depression.
In Brief
A Phase 3 clinical trial evaluating Placebo and SM-13496 for Bipolar Depression. Completed, enrolled 525 participants across 8 sites in 8 countries.
Detailed Summary
The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with Bipolar I Depression.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Depression
CountriesJapan, Lithuania, Malaysia, Philippines, Russia, Slovakia, Taiwan, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 2013
Enrollment StartFeb 2014
Primary CompletionFeb 2017
Study CompletionFeb 2017
TodayJul 2026
First PostedNov 18, 2013
Enrollment StartFeb 19, 2014
Primary CompletionFeb 1, 2017
Study CompletionFeb 16, 2017
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 12.6 years ago
Interventions
Placebodrug
Placebo comparator
SM-13496drug
SM-13496 20mg for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6
SM-13496drug
SM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6, 80 mg/day on Day 7 and beginning Day 8 flexibly dosed 80-120 mg/day for Weeks 2-6