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CompletedNCT05593029

SEP-363856 for depression

This study is completed in the United States, in Canada, in Bulgaria, .... It is testing SEP-363856 for depression.

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.

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In plain English

Key information made simple

This summary needs review. Please check the official study record and contact the research team for details.

Your next step

Check the study details

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  • 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

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Study start dateStarted: November 9, 2022
Recruitment status
Completed
Enrollment listed in the registry
929
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor type
Pharmaceutical company
Study type
Drug
Intervention type
Medication / drug, OTHER
Study phase
Phase 2Usually explores whether the intervention may work, while continuing to monitor safety.
Locations
United States, Canada, Bulgaria, ...
Age range
From 18 Years to 65 Years
Official registry ID
NCT05593029
Official title
A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Flexible Doses of SEP-363856 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder

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

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The overall study status can differ from each site's status. Open a country to see its locations and their registry status.

Bulgaria · 5 sites
  • Diagnostic Consultive Center Higya AD
    Pazardzhik
    Site status: Not listed — confirm with the team
  • Ambulatory for Group Practice for Specialized Psychiatrics Help PHILIPOPOLIS OOD
    Plovdiv
    Site status: Not listed — confirm with the team
  • Medical Center Sveti Naum
    Sofia
    Site status: Not listed — confirm with the team
  • DCC-Mladost M OOD
    Varna
    Site status: Not listed — confirm with the team
  • Mental Health Center Vratsa
    Vratsa
    Site status: Not listed — confirm with the team
Canada · 3 sites
  • Chatham-Kent Clinical Trials Research Centre
    Chatham, Ontario
    Site status: Not listed — confirm with the team
  • Institute of Mental Health Research IMHR
    Ottawa, Ontario
    Site status: Not listed — confirm with the team
  • Centre for Addiction and Mental Health (CAMH & University of Toronto)
    Toronto, Ontario
    Site status: Not listed — confirm with the team
Czechia · 4 sites
  • BRAIN-SOULTHERAPY s.r.o.
    Kladno, Central Bohemia
    Site status: Not listed — confirm with the team
  • A-Shine s.r.o.
    Ptzen, Plzeň Region
    Site status: Not listed — confirm with the team
  • National Institute of Mental Health
    Klecany
    Site status: Not listed — confirm with the team
  • Clintrial s.r.o.
    Prague
    Site status: Not listed — confirm with the team
Germany · 5 sites
  • Velocity Clinical Research Wiesbaden
    Wiesbaden, Hesse
    Site status: Not listed — confirm with the team
  • Pharmakologisches Studienzentrum Chemnitz GmbH
    Chemnitz, MA
    Site status: Not listed — confirm with the team
  • Private Practice Kusserow
    Stralsund, Mecklenburg-Vorpommern
    Site status: Not listed — confirm with the team
  • Somni Bene Institut for Medical Research
    Schwerin, Mecklenburg
    Site status: Not listed — confirm with the team
  • Arztepartnerschaft Dr. med. J. Springhub/ W. Schwarz-Studienzentrum Nord-West
    Westerstede
    Site status: Not listed — confirm with the team
Hungary · 2 sites
  • ClinExpert Kft.
    Budapest
    Site status: Not listed — confirm with the team
  • Semmelweis University
    Budapest
    Site status: Not listed — confirm with the team
Poland · 5 sites
  • Praktyka Lekarska Malgorzata Wojtanowska-Bogacka
    Poznan, Greater Poland Voivodeship
    Site status: Not listed — confirm with the team
  • Osrodek Badan Klinicznych CLINSANTE
    Bydgoszcz, Kuyavian-Pomeranian Voivodeship
    Site status: Not listed — confirm with the team
  • MlynowaMed - Bialystok
    Bialystok, OH
    Site status: Not listed — confirm with the team
  • Centrum Medyczne Luxmed Sp.z. o.o.
    Lublin
    Site status: Not listed — confirm with the team
  • Indywidualna SpecjalistycznaPraktyka Lekarska AgnieszkaRemlinger-Molenda
    Szkolkarska 32
    Site status: Not listed — confirm with the team
United States · 53 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama
    Site status: Not listed — confirm with the team
  • Scottsdale Clinical Research
    Scottsdale, Arizona
    Site status: Not listed — confirm with the team
  • DelSol Research
    Tucson, Arizona
    Site status: Not listed — confirm with the team
  • Pillar Clinical Research
    Bentonville, Arkansas
    Site status: Not listed — confirm with the team
  • ProScience Research Group
    Culver City, California
    Site status: Not listed — confirm with the team
  • Wr-Pri, Llc
    Encino, California
    Site status: Not listed — confirm with the team
  • Collaborative NeuroScience Research , LLC
    Garden Grove, California
    Site status: Not listed — confirm with the team
  • Alliance Research
    Long Beach, California
    Site status: Not listed — confirm with the team
  • ATP Clinical Research, Inc.
    Orange, California
    Site status: Not listed — confirm with the team
  • Anderson Clinical Research
    Redlands, California
    Site status: Not listed — confirm with the team
  • California Mental Behavioral Health
    Santee, California
    Site status: Not listed — confirm with the team
  • Schuster Medical Research Institute SMRI
    Sherman Oaks, California
    Site status: Not listed — confirm with the team
  • Viking Clinical Research
    Temecula, California
    Site status: Not listed — confirm with the team
  • Collaborative Neuroscience Research LLC
    Torrance, California
    Site status: Not listed — confirm with the team
  • Sunwise Clinical Research with is in Lafayette, CA
    Walnut Creek, California
    Site status: Not listed — confirm with the team
  • Institute of Living Hartford Hospital
    Hartford, Connecticut
    Site status: Not listed — confirm with the team
  • Clinical Neuroscience Solutions Inc.
    Jacksonville, Florida
    Site status: Not listed — confirm with the team
  • K2 Medical Research
    Maitland, 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. dba CNS Healthcare
    Orlando, Florida
    Site status: Not listed — confirm with the team
  • Combined Research Orlando Phase I-IV
    Orlando, Florida
    Site status: Not listed — confirm with the team
  • K2 Medical Research
    Tampa, Florida
    Site status: Not listed — confirm with the team
  • Interventional Psychiatry of Tampa Bay
    Tampa, Florida
    Site status: Not listed — confirm with the team
  • Advanced Discovery Research LLC
    Atlanta, Georgia
    Site status: Not listed — confirm with the team
  • Renew Health Clinical Research
    Snellville, Georgia
    Site status: Not listed — confirm with the team
  • MetroMed Clinical Trials
    Chicago, Illinois
    Site status: Not listed — confirm with the team
  • AMR Convention Research
    Warrenville, Illinois
    Site status: Not listed — confirm with the team
  • Benchmark Research
    Shreveport, Louisiana
    Site status: Not listed — confirm with the team
  • Cenexel CBH (CBH Health)
    Gaithersburg, Maryland
    Site status: Not listed — confirm with the team
  • Copley Clinical
    Boston, Massachusetts
    Site status: Not listed — confirm with the team
  • Boston Clinical Trials
    Roslindale, Massachusetts
    Site status: Not listed — confirm with the team
  • Adams Clinical
    Watertown, Massachusetts
    Site status: Not listed — confirm with the team
  • Vitalix Clinical
    Worcester, Massachusetts
    Site status: Not listed — confirm with the team
  • Neurobehavioral Medicine Group
    Bloomfield Hills, Michigan
    Site status: Not listed — confirm with the team
  • Precise Research Centers
    Flowood, Mississippi
    Site status: Not listed — confirm with the team
  • Center for Emotional Fitness
    Cherry Hill, New Jersey
    Site status: Not listed — confirm with the team
  • Integrative Clinical Trials
    Brooklyn, New York
    Site status: Not listed — confirm with the team
  • Basil Clinical
    Inwood, New York
    Site status: Not listed — confirm with the team
  • Berman Clinical
    New York, New York
    Site status: Not listed — confirm with the team
  • Manhattan Behavioral Medicine PLLC
    New York, New York
    Site status: Not listed — confirm with the team
  • The Medical Research Network, LLC
    New York, New York
    Site status: Not listed — confirm with the team
  • Patient Priority Clinical Studies LLC
    Cincinnati, Ohio
    Site status: Not listed — confirm with the team
  • The Ohio State University
    Columbus, Ohio
    Site status: Not listed — confirm with the team
  • Sooner Clinical Research
    Oklahoma City, Oklahoma
    Site status: Not listed — confirm with the team
  • Suburban Research Associates
    West Chester, Pennsylvania
    Site status: Not listed — confirm with the team
  • Clinical Neuroscience Solutions Inc.
    Memphis, Tennessee
    Site status: Not listed — confirm with the team
  • Donald J. Garcia, Jr., MD, PA
    Austin, Texas
    Site status: Not listed — confirm with the team
  • Community Clinical Research, Inc.
    Austin, Texas
    Site status: Not listed — confirm with the team
  • FutureSearch Trials of Dallas
    Dallas, Texas
    Site status: Not listed — confirm with the team
  • North Texas Clinical Trials
    Fort Worth, Texas
    Site status: Not listed — confirm with the team
  • DM Clinical Research - Belliare
    Houston, Texas
    Site status: Not listed — confirm with the team
  • Psychiatric And Behavioral Solutions, LLC
    Millcreek, Utah
    Site status: Not listed — confirm with the team
  • Core Clinical Research
    Everett, Washington
    Site status: Not listed — confirm with the team
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-363856, 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 broad, 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 Otsuka Pharmaceutical Development & Commercialization, Inc., which appears to be a pharmaceutical company. Sponsor website: https://www.otsuka.co.jp/en/. 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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