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TerminatedNCT05227209
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).
Researchers are studying SEP-4199 CR, tracking side effects to assess long-term safety and tolerability 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 studying SEP-4199 CR, tracking side effects to assess long-term safety and tolerability 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 · Anaheim, United States and 55 more locationsSee all locations and recruitment
- Activities
- Medication described in the protocol
- 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: March 17, 2022
- Recruitment status
- Terminated
- Enrollment listed in the registry
- 64
- 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, Bulgaria, Japan
- Age range
- From 18 Years to 65 Years
- Official registry ID
- NCT05227209
- Official title
Show the full official title
A 12-Month Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Effectiveness of 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 · Anaheim, United States · Imperial, United States
53 more locations
- Riverside, United States
- Torrance, United States
- Gainesville, United States
- Jacksonville, United States
- Miami, United States
- Orlando, United States
- Atlanta, United States
- Marietta, United States
- Warrenville, United States
- Saint Charles, United States
- Lincoln, United States
- Cherry Hill, 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
- Kardzhali, Bulgaria
- Plovdiv, Bulgaria
- Rousse, Bulgaria
- Sofia, Bulgaria
- Tsarevo, Bulgaria
- Varna, Bulgaria
- Fukuoka, Japan
- Kitakyushu, Japan
- Kitakyushu-shi, Japan
- Kurume-shi, Japan
- Omuta-shi, Japan
- Shirakawa-shi, Japan
- Sapporo, Japan
- Kobe, Japan
- Kagoshima, Japan
- Kawasaki, Japan
- Sagamihara-shi, Japan
- Yokohama, Japan
- Kumamoto, 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
A listed location does not confirm current availability.
Questions about this study
What is this study about?
Researchers are studying SEP-4199 CR, tracking side effects to assess long-term safety and tolerability 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.
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.
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