CompletedNCT01986101
SM-13496 Compared With Placebo for Bipolarity-Related Depression
About this title
A Phase III Study of SM-13496 in Patients With Bipolar I Depression.
Read the official source — NCT01986101Researchers compared SM-13496 and placebo to find out how the approaches affected depression symptoms in people with bipolarity type I during a depressive episode.
Medication studyAges 18–74Multiple countries
Understand this study
What did researchers investigate?
Researchers compared SM-13496 and placebo to find out how the approaches affected depression symptoms in people with bipolarity type I during a depressive episode.
Who was this study for?
This study was for people with bipolarity. Listed age limits: 18 years to 74 years. Other eligibility criteria applied.
- Listed locations
- Tokyo and 7 more locationsSee all locations and recruitment
- Study phase
- Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Study information
Study start dateStarted: February 19, 2014
- Recruitment status
- Completed
- Enrollment listed in the registry
- 525
- Sponsor
- Sumitomo Pharma Co., Ltd.
- Sponsor type
- Pharmaceutical company
- Study type
- Drug
- Intervention type
- Medication / drug
- Study phase
- Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
- Locations
- Japan, Lithuania, Malaysia, ...
- Age range
- From 18 Years to 74 Years
- Official registry ID
- NCT01986101
- Official title
Show the full official title
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of SM-13496 for the Treatment of Bipolar I Depression.
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Recruitment & locations
CompletedTokyo, Japan · Kaunas, Lithuania · Kuala Lumpur, Malaysia
6 more locations
- Manila, Philippines
- Moscow, Russia
- Žilina, Slovakia
- Taipei, Taiwan
- Kiev, Ukraine
- Russia
Questions about this study
What did researchers investigate?
Researchers compared SM-13496 and placebo to find out how the approaches affected depression symptoms in people with bipolarity type I during a depressive episode.
Who is behind this study?
The study sponsor is Sumitomo Pharma Co., Ltd., a pharmaceutical company.
Did this study involve medication?
Yes. The study involved medication, including Placebo and SM-13496.
Who was this study for?
This study was for people with bipolarity. Listed age limits: 18 years to 74 years. Other eligibility criteria applied.
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