Questions about this study?
The HopeStage team will email you.
TerminatedNCT05169710
A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolarity type I.
Researchers are comparing SEP-4199 CR 200 mg, SEP-4199 CR 400 mg and placebo to find out how the approaches affect depression symptoms in people with bipolarity type I during a depressive episode.
Medication studyAges 18–65Multiple countries
Understand this study
What is this study about?
Researchers are comparing SEP-4199 CR 200 mg, SEP-4199 CR 400 mg and placebo to find out how the approaches affect depression symptoms in people with bipolarity type I during a depressive episode.
Who could participate?
This study is for people with type I bipolarity. Listed age limits: 18 years to 65 years. Other eligibility criteria apply.
- Listed locations
- Huntsville, United States · Bryant, United States and 70 more locationsSee all locations and recruitment
- Activities
- Medication described in the protocol · Placebo comparator
- Compensation
- Payment and expense reimbursement have not been verified.
What to know before participating
A point to clarify
This summary does not cover all risks or eligibility requirements. What risks or changes to my care would apply to me?
Things to check before joining
Study start dateStarted: December 21, 2021
- Recruitment status
- Terminated
- Enrollment listed in the registry
- 83
- Sponsor
- Sumitomo Pharma America, Inc.
- 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
- United States, Canada, Bulgaria, ...
- Age range
- From 18 Years to 65 Years
- Official registry ID
- NCT05169710
- Official title
Show the full official title
A Multi-region, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating SEP-4199 Controlled Release (CR) for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression)
Recruitment & locations
TerminatedHuntsville, United States · Bryant, United States · Anaheim, United States
69 more locations
- Imperial, United States
- Riverside, United States
- Santa Rosa, United States
- Torrance, United States
- Clermont, United States
- Gainesville, United States
- Jacksonville, United States
- Miami, United States
- Orlando, United States
- Tampa, United States
- Atlanta, United States
- Marietta, United States
- Warrenville, United States
- Louisville, United States
- Saint Charles, United States
- Lincoln, United States
- Cherry Hill, United States
- Princeton, United States
- Buffalo, United States
- Rochester, United States
- Staten Island, United States
- Charlotte, United States
- Avon Lake, United States
- North Canton, United States
- Oklahoma City, United States
- Allentown, United States
- Austin, United States
- Houston, United States
- The Woodlands, United States
- St. George, United States
- Kardzhali, Bulgaria
- Plovdiv, Bulgaria
- Rousse, Bulgaria
- Sofia, Bulgaria
- Tsarev Brod, Bulgaria
- Varna, Bulgaria
- Markham, Canada
- Fukuoka, Japan
- Kitakyushu, Japan
- Kitakyushu-shi, Japan
- Kurume-shi, Japan
- Omuta-shi, Japan
- Shirakawa-shi, Japan
- Sapporo, Japan
- Kobe, Japan
- Kagoshima, Japan
- Kawasaki-shi, Japan
- Sagamihara-shi, Japan
- Yokohama, Japan
- Kumamoto, Japan
- Naha, Japan
- Urasoe-shi, Japan
- Karatsu-shi, Japan
- Bunkyō City, Japan
- Meguro-ku, Japan
- Minatoku, Japan
- Nakano, Japan
- Setagaya-ku, Japan
- Shibuya-ku, Japan
- Shinagawa-ku, Japan
- Shinjuku-ku, Japan
- Taito-ku, Japan
- Toshima-ku, Japan
- Brasov, Romania
- Bucharest, Romania
- Craiova, Romania
- Iași, Romania
- Rimavská Sobota, Slovakia
- Vranov nad Topľou, Slovakia
A listed location does not confirm current availability.
Questions about this study
What is this study about?
Researchers are comparing SEP-4199 CR 200 mg, SEP-4199 CR 400 mg and placebo to find out how the approaches affect 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.
Does this study involve medication?
Yes. The study involves medication, including SEP-4199 CR 200 mg, SEP-4199 CR 400 mg and Placebo.
Who can participate?
This study is for people with type I bipolarity. Listed age limits: 18 years to 65 years. Other eligibility criteria apply.
Is this study still recruiting?
The registry lists this study as terminated.
Want to find a study that may fit you better?
Answer a few simple questions to explore HopeStage studies by condition, country, and situation.
Find a study that may fit meRelated studies
16-week Comparative Effectiveness Trial of Lamotrigine vs. Fluoxetine for Depression in bipolarity
A Clinical Trial to Determine the Long-term Safety and Tolerability of an Investigational Drug in People With Major Depressive Episode Associated With Bipolarity type I (Bipolar I Depression).