CompletedNCT03543410
A Clinical Study to Test the Effectiveness of an Investigational Drug to Treat People That Have Major Depressive Episodes When They Have Bipolar 1 Depression
Researchers compared SEP-4199 200 mg, SEP-4199 400 mg and placebo to find out how the approaches affected depression symptoms in people with bipolarity type I during a depressive episode.
Medication studyAges 18–65Multiple countries
Understand this study
What did researchers investigate?
Researchers compared SEP-4199 200 mg, SEP-4199 400 mg 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 type I bipolarity. Listed age limits: 18 years to 65 years. Other eligibility criteria applied.
- Listed locations
- Cerritos, United States · Garden Grove, United States and 51 more locationsSee all locations and recruitment
- Activities
- Medication described in the protocol · Placebo comparator
- Compensation
- Payment and expense reimbursement have not been verified.
Study information
Study start dateStarted: June 26, 2018
- Recruitment status
- Completed
- Enrollment listed in the registry
- 344
- Sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Pharmaceutical company
- Study type
- Drug
- Intervention type
- Medication / drug
- Study phase
- Phase 2Usually explores whether the intervention may work, while continuing to monitor safety.
- Locations
- United States, Bulgaria, Japan, ...
- Age range
- From 18 Years to 65 Years
- Official registry ID
- NCT03543410
- Official title
Show the full official title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of SEP-4199 for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression)
Recruitment & locations
CompletedCerritos, United States · Garden Grove, United States · San Diego, United States
50 more locations
- Jacksonville, United States
- Orlando, United States
- Atlanta, United States
- Everett, United States
- Burgas, Bulgaria
- Kardzhali, Bulgaria
- Kazanlak, Bulgaria
- Rousse, Bulgaria
- Shumen, Bulgaria
- Sofia, Bulgaria
- Fukuoka, Japan
- Fukushima, Japan
- Hyōgo, Japan
- Kanagawa, Japan
- Kyoto, Japan
- Minato-Ku, Tokyo, Japan
- Okayama, Japan
- Osaka, Japan
- Tokyo, Japan
- Bydgoszcz, Poland
- Leszno, Poland
- Lublin, Poland
- Poznan, Poland
- Pruszcz Gdański, Poland
- Torun, Poland
- Lipetsk, Russia
- Moscow, Russia
- Nizhny Novgorod, Russia
- Omsk, Russia
- Rostov-on-Don, Russia
- Saint Petersburg, Russia
- Saratov, Russia
- Tomsk, Russia
- Belgrade, Serbia
- Kovin, Serbia
- Kragujevac, Serbia
- Bratislava, Slovakia
- Košice, Slovakia
- Rimavská Sobota, Slovakia
- Svidník, Slovakia
- Vranov nad Topľou, Slovakia
- Ivano-Frankivsk, Ukraine
- Kharkiv, Ukraine
- Kherson, Ukraine
- Kyiv, Ukraine
- Odesa, Ukraine
- Smila, Ukraine
- Uzhhorod, Ukraine
- Vinnytsia, Ukraine
- Russia
Questions about this study
What did researchers investigate?
Researchers compared SEP-4199 200 mg, SEP-4199 400 mg 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 America, Inc., a pharmaceutical company.
Did this study involve medication?
Yes. The study involved medication, including SEP-4199 200 mg, SEP-4199 400 mg and Placebo.
Who was this study for?
This study was for people with type I bipolarity. Listed age limits: 18 years to 65 years. Other eligibility criteria applied.
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