Trials / Completed
CompletedNCT01986101
A Phase III Study of SM-13496 in Patients With Bipolar I Depression.
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of SM-13496 for the Treatment of Bipolar I Depression.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 525 (actual)
- Sponsor
- Sumitomo Pharma Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 74 Years
- Healthy volunteers
- Not accepted
Summary
The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with Bipolar I Depression.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Placebo comparator |
| DRUG | SM-13496 | SM-13496 20mg for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6 |
| DRUG | SM-13496 | 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 |
Timeline
- Start date
- 2014-02-19
- Primary completion
- 2017-02-01
- Completion
- 2017-02-16
- First posted
- 2013-11-18
- Last updated
- 2022-04-12
- Results posted
- 2019-07-25
Locations
8 sites across 8 countries: Japan, Lithuania, Malaysia, Philippines, Russia, Slovakia, Taiwan, Ukraine
Source: ClinicalTrials.gov record NCT01986101. Inclusion in this directory is not an endorsement.