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TerminatedNCT05169710

SEP-4199 CR 200 mg for depression

This study was terminated in the United States, in Canada, in Bulgaria, .... It is testing SEP-4199 CR 200 mg 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.

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In plain English

Key information made simple

What is this study testing?

This study is testing whether an Investigational Drug may be useful for adults experiencing depression.

What would participation involve?

Participants may receive an Investigational Drug, 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 Canada, and in Japan.

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.

View official study record (opens in a new tab)

  • Recruitment and eligibility

    Is a site open, and who can take part?

  • Visits and time

    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

Study clarity

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
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)

Check recruitment and locations

Recruitment checked against the registry by HopeStage on . Registry information can change. Always confirm availability with the research team.

View official study record (opens in a new tab)

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
    Tsarev Brod
    Site status: Not listed — confirm with the team
  • DCC Mladost-M Varna OOD 15, Republika Blvd., MC Mladost, 3rd floor
    Varna
    Site status: Not listed — confirm with the team
Canada · 1 site
  • AMNDX Inc.
    Markham, Ontario
    Site status: Not listed — confirm with the team
Japan · 35 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-shi, 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
  • Akari Clinic
    Naha, Okinawa
    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
Romania · 7 sites
  • Spitalul Clinic de Psihiatrie si Neurologie Brasov, Sectia Psihiatrie Clinică I
    Brasov
    Site status: Not listed — confirm with the team
  • Spitalul Clinic de Psihiatrie ''Prof. Dr. Alexandru Obregia''
    Bucharest
    Site status: Not listed — confirm with the team
  • Spitalul Clinic de Psihiatrie
    Bucharest
    Site status: Not listed — confirm with the team
  • Sectia Psihiatrie, Centrul de Evaluare si Tratament al Toxicodependentelor pentru Tineri "Sfantul Stelian", Sectia Psihiatrie
    Bucharest
    Site status: Not listed — confirm with the team
  • Institutul Privat De Cercetări Melchisedec, Pentru Boli Autoimune, Ereditare Şi Rare - I.P.C.M.
    Craiova
    Site status: Not listed — confirm with the team
  • Institutul de Psihiatrie Socola Iasi, Sectia Psihiatrie I Femei
    Iași
    Site status: Not listed — confirm with the team
  • Institutul de Psihiatrie Socola Iasi, Sectia Psihiatrie III Acuti
    Iași
    Site status: Not listed — confirm with the team
Slovakia · 2 sites
  • PsychoLine s. r. o., Psychiatricka ambulancia
    Rimavská Sobota
    Site status: Not listed — confirm with the team
  • Crystal Comfort s.r.o., Psychiatricka ambulancia
    Vranov nad Topľou
    Site status: Not listed — confirm with the team
United States · 34 sites
  • University of Alabama at Birmingham Huntsville Regional Medical Campus
    Huntsville, Alabama
    Site status: Not listed — confirm with the team
  • Sanro Clinical Research Group LLC
    Bryant, Arkansas
    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
  • Siyan Clinical Research
    Santa Rosa, California
    Site status: Not listed — confirm with the team
  • Collaborative Neuroscience Research, LLC
    Torrance, California
    Site status: Not listed — confirm with the team
  • Vertex Research Group
    Clermont, Florida
    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
  • Central Miami Medical Institute
    Miami, Florida
    Site status: Not listed — confirm with the team
  • Clinical Neuroscience Solutions, Inc.
    Orlando, Florida
    Site status: Not listed — confirm with the team
  • GCP Clinical Research LLC
    Tampa, 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
  • Dept. of Psychiatry & Behavioral Sciences, University of Louisville School of Medicine
    Louisville, Kentucky
    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
  • Global Medical Institutes, LLC
    Princeton, New Jersey
    Site status: Not listed — confirm with the team
  • UB Department of Psychiatry
    Buffalo, New York
    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
  • Integrated Clinical Research
    St. George, Utah
    Site status: Not listed — confirm with the team

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Study ID: NCT05169710. 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 CR 200 mg, SEP-4199 CR 400 mg, Placebo. 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 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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