This study is completed in the United States, in Bulgaria, in Japan, .... It is testing SEP-4199 for depression.
Depression, BipolarityDrugFrom 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 may be useful for adults experiencing depression.
What would participation involve?
Participants may receive SEP-4199, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Bulgaria, in Japan, and in Poland.
Who is it mainly for?
This study appears to be mainly for adults with depression.
What should you check before joining?
Ask about the dose, safety monitoring, and possible side effects, whether there is placebo, randomization, or 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: 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
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)
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 · 6 sites
Mental Health Centre -Prof. Dr. Ivan Temkov - Burgas EOOD
Burgas
Site status: Not listed — confirm with the team
State Psychiatric Hospital-Kardzhali
Kardzhali
Site status: Not listed — confirm with the team
MHAT-Dr. Hristo Stambolski EOOD, Department of Psychiatry
Kazanlak
Site status: Not listed — confirm with the team
Mental Health Center - Ruse EOOD
Rousse
Site status: Not listed — confirm with the team
Neli Nikolova Todorova, MD ,State Psychatric Hospital - s. Tsarev brod
Shumen
Site status: Not listed — confirm with the team
Mental Health Center - Sofia EOOD
Sofia
Site status: Not listed — confirm with the team
Japan · 35 sites
Fukuoka University Hospital
Fukuoka
Site status: Not listed — confirm with the team
Hatakeyama Clinic, Department of Psychiatry
Fukuoka
Site status: Not listed — confirm with the team
Hiro Mental Clinic, Department of Psychiatry
Fukuoka
Site status: Not listed — confirm with the team
Kokura Mental Clinic
Fukuoka
Site status: Not listed — confirm with the team
Kuramitsu Hospital, Department of Psychiatry
Fukuoka
Site status: Not listed — confirm with the team
Shinseikai Kaku Mental Clinic, Department of Psychiatry
Fukuoka
Site status: Not listed — confirm with the team
Someikai Kanagami Clinic, Department of Psychiatry
Fukuoka
Site status: Not listed — confirm with the team
Jisenkai Nanko Psychiatric Institute, Department of Psychiatry
Fukushima
Site status: Not listed — confirm with the team
Takahashi Psychiatric Clinic
Hyōgo
Site status: Not listed — confirm with the team
Azamino Mental clinic, Department of Psychiatry
Kanagawa
Site status: Not listed — confirm with the team
Medical Corporation Seishinkai Kishiro Mental Clinic, Department of Psychiatry
Kanagawa
Site status: Not listed — confirm with the team
Musashikosugi J. Kokorono Clinic
Kanagawa
Site status: Not listed — confirm with the team
Yokohama Onoecho Clinic, Department of Psychiatry
Kanagawa
Site status: Not listed — confirm with the team
Yutaka Clinic
Kanagawa
Site status: Not listed — confirm with the team
SagaArashiyama / Tanaka Clinic, Department of Psychiatry
Kyoto
Site status: Not listed — confirm with the team
Minami-aoyama Anique Street Clinic, Department of Psychiatry
Minato-Ku, Tokyo
Site status: Not listed — confirm with the team
Clinic Sophia
Okayama
Site status: Not listed — confirm with the team
Nagaokai Neyagawa Sanitorium
Osaka
Site status: Not listed — confirm with the team
Asakayama Hospital
Osaka
Site status: Not listed — confirm with the team
Koshokai Ainhanazono Hospital
Osaka
Site status: Not listed — confirm with the team
Osaka Institute of Clinical Psychiatry Shin-abuyama Hospital
Osaka
Site status: Not listed — confirm with the team
Etoh Mental Clinic Meguro, Department of Psychiatry
Tokyo
Site status: Not listed — confirm with the team
Himorogi Psychiatric Institute, Department of Psychiatry
Tokyo
Site status: Not listed — confirm with the team
JCHO Yokyo Shinjuku Medical Center
Tokyo
Site status: Not listed — confirm with the team
Jisenkai Hozumi Himorogi Clinic, Department of Psychiatry
Tokyo
Site status: Not listed — confirm with the team
Maynds Tower Mental Clinic, Department of Psychiatry
Tokyo
Site status: Not listed — confirm with the team
Nishi-shinjuku Concieria Clnic
Tokyo
Site status: Not listed — confirm with the team
Ohwa Mental clinic, Department of Psychiatry
Tokyo
Site status: Not listed — confirm with the team
Sangenjaya Nakamura Mental Clinic, Department of Psychiatry
Tokyo
Site status: Not listed — confirm with the team
Sangenjaya Neurology-Psychosomatic Clinic, Department of Psychiatry
Tokyo
Site status: Not listed — confirm with the team
Senzoku Psychosomatic Clinic, Department of Psychiatry
Tokyo
Site status: Not listed — confirm with the team
Shinjuku Research Park Clinic
Tokyo
Site status: Not listed — confirm with the team
Tamaki Clinic, Department of Psychiatry
Tokyo
Site status: Not listed — confirm with the team
Uguisudani Mental Clinic, Department of Psychiatry
Tokyo
Site status: Not listed — confirm with the team
Yoyogi Mental Clinic
Tokyo
Site status: Not listed — confirm with the team
Poland · 7 sites
Przychodnia Srodmiescie Sp. z.o.o.
Bydgoszcz
Site status: Not listed — confirm with the team
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
Leszno
Site status: Not listed — confirm with the team
Specjalistyczna Praktyka Lekarska Marek Domanski
Lublin
Site status: Not listed — confirm with the team
Filip Rybakowski Specjalistyczna Praktka Lekarska
Poznan
Site status: Not listed — confirm with the team
Poradnia Zdrowia Psychicznego "Syntonia"
Pruszcz Gdański
Site status: Not listed — confirm with the team
Gabinet Lekarski Torunskie Centrum PsychiatriI NEUROMED
Torun
Site status: Not listed — confirm with the team
Osrodek Badan Klinicznych Clinsante Spolka Cywilna
Torun
Site status: Not listed — confirm with the team
Russia · 10 sites
Lipetsk regional psychoneurological hospital
Lipetsk
Site status: Not listed — confirm with the team
State Budgetary Institution of Healthare of the City of Moscow "Psychiatric clinical Hospital #4 n.a. P.B. Gannushkin of the Department of Healthcare of the City o Moscow" Branch "Psychiatric hospital n.a. V.A. Gilyarovsky"
Moscow
Site status: Not listed — confirm with the team
State Budgetary Institution of Healthcare of Nizhniy Novgorod region "Clinical Psychiatric Hospital #1 of Nizhniy Novgorod"
Nizhny Novgorod
Site status: Not listed — confirm with the team
Budgetary Institution of Healthcare of Omsk region "Clinical Psychiatric Hospital named after N.N. Solodnikov"
Omsk
Site status: Not listed — confirm with the team
Limited Liability Company "Treatment and Rehabilitational Scientific Center Phoenix"
Rostov-on-Don
Site status: Not listed — confirm with the team
Saint Petersburg State Institution of Healthcare "Psychiatric Hospital of Sain Nikolai hudotvorets "
Saint Petersburg
Site status: Not listed — confirm with the team
Federal State Budgetary Institution "National Medical Research Centre of psychiatry and nuerology named after V.M. Bekhterev" of the Ministry of Healthcare of the Russian Federation, department #12
Saint Petersburg
Site status: Not listed — confirm with the team
Stain Petersburg State Budgetary Institution of Healthcare "Psychoneurological Dispensary #1"
Saint Petersburg
Site status: Not listed — confirm with the team
State Institution of Healtcare "Regional Clinical Psychiatric Hospital of Saint Sofia"
Regional Psychoneurological Hospital #3, Department of Neurosis and Borderline States # 8
Ivano-Frankivsk
Site status: Not listed — confirm with the team
State Institution Institue of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Unit of Emergency sychiatry and Narcology
Kharkiv
Site status: Not listed — confirm with the team
State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Unit of Borderline Psychiatry
Kharkiv
Site status: Not listed — confirm with the team
CI Kherson Regional Psychiatric Hospital of Kherson Regional Council, Male Dep of Psychiatry #3, Female Dep of Psychiatry #10
Kherson
Site status: Not listed — confirm with the team
Communal Institution (CI) of Kyiv Regional Council regional Psychiatric and Narcological Medical Assocation, Dep #10 (male), Dep #2 (female)
Kyiv
Site status: Not listed — confirm with the team
Communal Institution Odesa regional Medical Center of Mental Health, Dep #6 (Male), Dep #12 (Female)
Odesa
Site status: Not listed — confirm with the team
Communal Institution Odesa Regional Psychiatric Hospital #2, Department #14 (female), Department #16 (male)
Odesa
Site status: Not listed — confirm with the team
Communal Institution Cherkasy regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12
Smila
Site status: Not listed — confirm with the team
Transcarpathian Regional Narcological Dispensary, Department of Psychiatry
Uzhhorod
Site status: Not listed — confirm with the team
communal Institution Acad. O.I. Yushchenko Vinnytsia Regional Psychoneurological hosital, Male Deparmtent #14, Female Department #15, Vinnytsia M.I. Pyrogov National Medical University, Chair of Psychiatry, Narcology and Psychotherapy with the Course of P
Vinnytsia
Site status: Not listed — confirm with the team
United States · 7 sites
CNS Research Science, Inc.
Cerritos, California
Site status: Not listed — confirm with the team
Collaborative Neuroscience Network, LLC
Garden Grove, California
Site status: Not listed — confirm with the team
Artemis Insitute for Clinical Research
San Diego, California
Site status: Not listed — confirm with the team
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida
Site status: Not listed — confirm with the team
Clinical Neuroscience Solutions, Inc.
Orlando, Florida
Site status: Not listed — confirm with the team
Atlanta Center for Medical Research
Atlanta, Georgia
Site status: Not listed — confirm with the team
Eastside Therapeutic Resource dba Core Clinical Research
Everett, Washington
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: NCT03543410. 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 depression. 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 200 mg, SEP-4199 400 mg, Placebo. Phase 2 studies usually explore whether the intervention may work, while continuing to monitor safety.
Who might this study be for?
This study may concern people with depression; 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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