Effectiveness of SEP-4199 Controlled Release (CR) in depression
This study was terminated in the United States, in Bulgaria, and in Japan. It is testing SEP-4199 Controlled Release (CR) for depression.
Bipolarity, DepressionDrugFrom 18 Years to 65 Years
The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.
Then choose your country and confirm availability with each study site.
In plain English
Key information made simple
What is this study testing?
This study is testing whether SEP-4199 CR may be useful for adults experiencing bipolarity.
What would participation involve?
Participants may receive SEP-4199 CR, attend study visits with the research team. The registry lists locations in Bulgaria, in Japan, and in the United States.
Who is it mainly for?
This study appears to be mainly for adults with bipolarity.
What should you check before joining?
Ask about the dose, safety monitoring, and possible side effects, whether there is a comparison group, how many visits or travel steps are needed, the exact eligibility criteria.
Your next step
Check the study details
Check the official source, then confirm these points with the research team.
Where are visits, can any be remote, and how much time is needed?
Costs and support
What costs, reimbursement or compensation apply?
Before joining
Questions to ask before joining
What are the exact eligibility criteria, and what could exclude someone?
How many visits, assessments, or follow-ups are expected, and over what period?
What risks, side effects, practical burdens, or alternatives should be understood first?
Who should be contacted to confirm locations, timing, compensation, and next steps?
Study clarity
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
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)
Check recruitment and locations
Recruitment checked against the registry by HopeStage on . Registry information can change. Always confirm availability with the research team.
The overall study status can differ from each site's status. Open a country to see its locations and their registry status.
Bulgaria · 10 sites
State Psychiatric Hospital - Kardzhali First Women Department Third Men Department
Kardzhali
Site status: Not listed — confirm with the team
Medical Center Mentalcare OOD
Plovdiv
Site status: Not listed — confirm with the team
Mental Health Center- Ruse EOOD Men Department for treatment of persons with acute psychotic disorders; Women Department for treatment of persons with acute psychotic disorders; Department "Daily stationary"
Rousse
Site status: Not listed — confirm with the team
Mental Health Center - Sofia EOOD
Sofia
Site status: Not listed — confirm with the team
Medical Center Sveti Naum EOOD
Sofia
Site status: Not listed — confirm with the team
DCC St. Vrach and St. St. Kuzma and Damian OOD
Sofia
Site status: Not listed — confirm with the team
Medical Center Hera EOOD
Sofia
Site status: Not listed — confirm with the team
Medical Center Intermedica OOD
Sofia
Site status: Not listed — confirm with the team
State Psychiatric Hospital - s. Tsarev brod First Department for Active Treatment - Men Second Department for Active Treatment - Men Women Department - Rehabilitation Sector Women Department - Acute Sector
Tsarevo
Site status: Not listed — confirm with the team
DCC Mladost-M Varna OOD
Varna
Site status: Not listed — confirm with the team
Japan · 34 sites
Hiro Mental Clinic
Fukuoka, Fukuoka
Site status: Not listed — confirm with the team
Shinseikai Kaku Mental Clinic
Fukuoka, Fukuoka
Site status: Not listed — confirm with the team
Mental Clinic Sakurazaka
Fukuoka, Fukuoka
Site status: Not listed — confirm with the team
Hatakeyama Clinic
Kitakyushu, Fukuoka
Site status: Not listed — confirm with the team
Someikai Kanagami Clinic
Kitakyushu-shi, Fukuoka
Site status: Not listed — confirm with the team
Kokura Mental Clinic
Kitakyushu-shi, Fukuoka
Site status: Not listed — confirm with the team
Hirota Clinic
Kurume-shi, Fukuoka
Site status: Not listed — confirm with the team
Shiranui Hospital
Omuta-shi, Fukuoka
Site status: Not listed — confirm with the team
Jisenkai Nanko Psychiatric Institute
Shirakawa-shi, Fukushima
Site status: Not listed — confirm with the team
Teine Keijinkai Hospital
Sapporo, Hokkaido
Site status: Not listed — confirm with the team
Tatsuta Clinic
Kobe, Hyōgo
Site status: Not listed — confirm with the team
Cerisier Heart Clinic
Kagoshima, Kagoshima-ken
Site status: Not listed — confirm with the team
Musashikosugi J Kokorono Clinic
Kawasaki, Kanagawa
Site status: Not listed — confirm with the team
Yutaka Clinic
Sagamihara-shi, Kanagawa
Site status: Not listed — confirm with the team
Azamino Mental Clinic
Yokohama, Kanagawa
Site status: Not listed — confirm with the team
Yamatenomori Kokorono Clinic
Yokohama, Kanagawa
Site status: Not listed — confirm with the team
Satokai Yuge Hospital
Kumamoto, Kumamoto
Site status: Not listed — confirm with the team
Shiroma Clinic
Urasoe-shi, Okinawa
Site status: Not listed — confirm with the team
Rainbow & Sea Hospital
Karatsu-shi, Saga-ken
Site status: Not listed — confirm with the team
Juntendo University Hospital
Bunkyō City, Tokyo-To
Site status: Not listed — confirm with the team
Senzoku Psychosomatic Clinic
Meguro-ku, Tokyo-To
Site status: Not listed — confirm with the team
Minami-Aoyama Antique Street Clinic
Minatoku, Tokyo-To
Site status: Not listed — confirm with the team
Heart Care Ginga Clinic
Nakano, Tokyo-To
Site status: Not listed — confirm with the team
Sangenjaya Nakamura Mental Clinic
Setagaya-Ku, Tokyo-To
Site status: Not listed — confirm with the team
Sangenjaya Neurology- Psychosomatic Clinic
Setagaya-Ku, Tokyo-To
Site status: Not listed — confirm with the team
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo-To
Site status: Not listed — confirm with the team
Maynds Tower Mental Clinic
Shibuya-ku, Tokyo-To
Site status: Not listed — confirm with the team
Sangubashi Kokorono Clinic
Shibuya-ku, Tokyo-To
Site status: Not listed — confirm with the team
Etoh Mental Clinic
Shinagawa-ku, Tokyo-To
Site status: Not listed — confirm with the team
Tamaki Clinic
Shinjuku-ku, Tokyo-To
Site status: Not listed — confirm with the team
Himorogi Psychiatric Institute
Shinjuku-Ku, Tokyo-To
Site status: Not listed — confirm with the team
Uguisudani Mental Clinic
Taito-ku, Tokyo-To
Site status: Not listed — confirm with the team
Ohwa Mental Clinic
Toshima-ku, Tokyo-To
Site status: Not listed — confirm with the team
Kitaikebukuro Kokoro No Clinic
Toshima-ku, Tokyo-To
Site status: Not listed — confirm with the team
United States · 25 sites
University of Alabama at Birmingham Huntsville Regional Medical Campus
Huntsville, Alabama
Site status: Not listed — confirm with the team
Advanced Research Center, Inc.
Anaheim, California
Site status: Not listed — confirm with the team
Sun Valley Research Center
Imperial, California
Site status: Not listed — confirm with the team
Clinical innovations, Inc.
Riverside, California
Site status: Not listed — confirm with the team
Collaborative Neuroscience Research, LLC
Torrance, California
Site status: Not listed — confirm with the team
Sarkis Clinical Trials
Gainesville, Florida
Site status: Not listed — confirm with the team
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida
Site status: Not listed — confirm with the team
Premier Clinical Research Institute, Inc
Miami, Florida
Site status: Not listed — confirm with the team
Clinical Neuroscience Solutions, Inc.
Orlando, Florida
Site status: Not listed — confirm with the team
Atlanta Behavioral Research, LLC
Atlanta, Georgia
Site status: Not listed — confirm with the team
Psych Atlanta, P.C.
Marietta, Georgia
Site status: Not listed — confirm with the team
AMR Conventions Research
Warrenville, Illinois
Site status: Not listed — confirm with the team
St. Charles Psychiatric Associates / Midwest Research Group
Saint Charles, Missouri
Site status: Not listed — confirm with the team
Alivation Research, LLC
Lincoln, Nebraska
Site status: Not listed — confirm with the team
Center for Emotional Fitness
Cherry Hill, New Jersey
Site status: Not listed — confirm with the team
Finger Lakes Clinical Research
Rochester, New York
Site status: Not listed — confirm with the team
Richmond Behavioral Associates ERG Clinical Research - New York PLLC
Staten Island, New York
Site status: Not listed — confirm with the team
New Hope Clinical Research
Charlotte, North Carolina
Site status: Not listed — confirm with the team
Quest Therapeutics of Avon Lake
Avon Lake, Ohio
Site status: Not listed — confirm with the team
Neuro-Behavioral Clinical Research, Inc
North Canton, Ohio
Site status: Not listed — confirm with the team
Sooner Clinical Research
Oklahoma City, Oklahoma
Site status: Not listed — confirm with the team
Lehigh Center for Clinical Research, LLC
Allentown, Pennsylvania
Site status: Not listed — confirm with the team
Community Clinical Research, Inc.
Austin, Texas
Site status: Not listed — confirm with the team
UTHealth Science Center at Houston
Houston, Texas
Site status: Not listed — confirm with the team
Family Psychiatry of The Woodlands
The Woodlands, Texas
Site status: Not listed — confirm with the team
Ask HopeStage to help me review this study
This record does not confirm open recruitment. We can help you understand it and explore other studies.
Study ID: NCT05227209. We help you review the study, but cannot decide medical eligibility.
In practice
For you
Participation may contribute to research. Personal benefit is not guaranteed.
Ask the research team to explain the activities, time commitment, and follow-up involved.
Study sites are listed. Confirm the relevant site and any travel before making plans.
Important
Not medical advice
Information from public sources.
Are you the study sponsor? Contact us to update this page: hi@hopestage.com
FAQ
Questions about this study
What is this study trying to understand?
This study is exploring medication or study treatment for people with bipolarity. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.
Does this study involve a medication?
This appears to be a medication / drug study involving SEP-4199 CR. Phase 3 studies are usually larger and aim to confirm effectiveness and safety in a broader group.
Who might this study be for?
This study may concern people with bipolarity; age range: From 18 Years to 65 Years. The criteria appear fairly specific, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.
What would I likely need to do?
You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.
What side effects, interactions, or treatment changes should I check?
If the study involves a medication, ask whether it is already approved, experimental, or being tested for a new use. Check possible side effects, interactions with current treatment, dose changes, monitoring, and what happens if you feel worse. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.
Will I need to travel or attend in-person visits?
The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.
Who is behind this study?
This study is sponsored by Sumitomo Pharma America, Inc., which appears to be a pharmaceutical company. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.
Can I still join this study?
The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.
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