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CompletedNCT05729373

SEP-363856 for anxiety

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

AnxietyDrugFrom 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 SEP-363856 may be useful for adults experiencing anxiety.

What would participation involve?

Participants may receive SEP-363856, 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 Estonia, and in Finland.

Who is it mainly for?

This study appears to be mainly for adults with anxiety.

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: March 8, 2023
Recruitment status
Completed
Enrollment listed in the registry
434
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor type
Pharmaceutical company
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 2, Phase 3This study spans more than one phase, so it may combine goals such as safety, dosing, and early effectiveness.
Locations
United States, Bulgaria, Estonia, ...
Age range
From 18 Years to 65 Years
Official registry ID
NCT05729373
Official title
A Phase 2/3, Randomized, Double-blind, Parallel Group, Placebo-controlled, Flexible-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in the Treatment of Adults With Generalized Anxiety Disorder

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 · 9 sites
  • Medical Center Mentalcare OOD
    Sofia, Plovdiv
    Site status: Not listed — confirm with the team
  • Medical Center Medconsult Pleven OOD
    Pleven
    Site status: Not listed — confirm with the team
  • MHC - Sofia, EOOD
    Sofia
    Site status: Not listed — confirm with the team
  • Medical Center "Sv.Naum"
    Sofia
    Site status: Not listed — confirm with the team
  • DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", 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
  • DCC "Mladost M" - Varna, OOD Site #156
    Varna
    Site status: Not listed — confirm with the team
  • DCC "Mladost M" - Varna, OOD Site #157
    Varna
    Site status: Not listed — confirm with the team
Estonia · 2 sites
  • Marienthali Kliinik
    Tallinn
    Site status: Not listed — confirm with the team
  • Tartu University Hospital
    Tartu
    Site status: Not listed — confirm with the team
Finland · 5 sites
  • Savon Psykiatripalvelu Oy
    Kuopio, Northern Savonia
    Site status: Not listed — confirm with the team
  • Aava Laakarikeskus - Aava Kamppi
    Helsinki
    Site status: Not listed — confirm with the team
  • Mederon Oy
    Helsinki
    Site status: Not listed — confirm with the team
  • Oulu Mentalcare Oy
    Oulu
    Site status: Not listed — confirm with the team
  • Satakunnan Psykiatripalvelu
    Tampere
    Site status: Not listed — confirm with the team
Japan · 14 sites
  • Uematsu Mental Clinic
    Chikugo-shi, Fukuoka
    Site status: Not listed — confirm with the team
  • 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
  • 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
  • Hayakawa Clinic
    Kure-shi, Hiroshima
    Site status: Not listed — confirm with the team
  • Higashi-Sapporo Mental Clinic
    Sapporo, Hokkaido
    Site status: Not listed — confirm with the team
  • Shimode Mental Clinic
    Sapporo, Hokkaido
    Site status: Not listed — confirm with the team
  • Akari Clinic
    Naha, Okinawa
    Site status: Not listed — confirm with the team
  • Barclay Imuro Mental Clinic
    Urasoe-shi, Okinawa
    Site status: Not listed — confirm with the team
  • Senzoku Psychosomatic Medicine Clinic
    Meguro-ku, 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
Slovakia · 5 sites
  • MENTUM, s.r.o.
    Bratislava
    Site status: Not listed — confirm with the team
  • Epamed sro
    Košice
    Site status: Not listed — confirm with the team
  • PsychoLine s.r.o.
    Rimavská Sobota
    Site status: Not listed — confirm with the team
  • Crystal Comfort s.r.o.
    Vranov nad Topľou
    Site status: Not listed — confirm with the team
  • BONA MEDIC, s.r.o.
    Zlaté Moravce
    Site status: Not listed — confirm with the team
Spain · 6 sites
  • Hospital Universitario Fundacion Alcorcon
    Alcorcón, Madrid
    Site status: Not listed — confirm with the team
  • Hospital Valle del Nalon
    Langreo, Principality of Asturias
    Site status: Not listed — confirm with the team
  • Hospital de la Santa Creu i Sant Pau
    Barcelona
    Site status: Not listed — confirm with the team
  • Institucion Hospitalaria Hestia Palau
    Barcelona
    Site status: Not listed — confirm with the team
  • Hospital Universitario Infanta Leonor
    Madrid
    Site status: Not listed — confirm with the team
  • Hospital de Antequera
    Málaga
    Site status: Not listed — confirm with the team
Sweden · 4 sites
  • Sahlgrenska Universitetssjukhuset - Östra sjukhuset
    Gothenburg
    Site status: Not listed — confirm with the team
  • ProbarE- Lund
    Lund
    Site status: Not listed — confirm with the team
  • PharmaSite AB Malmö
    Malmö
    Site status: Not listed — confirm with the team
  • ProbarE- Stockholm
    Stockholm
    Site status: Not listed — confirm with the team
United States · 38 sites
  • University of Alabama at Birmingham
    Huntsville, Alabama
    Site status: Not listed — confirm with the team
  • IMA Clinical Research Phoenix
    Phoenix, Arizona
    Site status: Not listed — confirm with the team
  • ProScience Research Group
    Culver City, California
    Site status: Not listed — confirm with the team
  • Excell Research, Inc.
    Oceanside, California
    Site status: Not listed — confirm with the team
  • Anderson Clinical Research
    Redlands, California
    Site status: Not listed — confirm with the team
  • California Neuroscience Research, LLC
    Sherman, California
    Site status: Not listed — confirm with the team
  • Schuster Medical Research Institute
    Sherman Oaks, California
    Site status: Not listed — confirm with the team
  • Viking Pharmaceutical Trials Inc. dba Viking Clinical Research
    Temecula, California
    Site status: Not listed — confirm with the team
  • CenExel Collaborative Neuroscience Research
    Torrance, California
    Site status: Not listed — confirm with the team
  • Pacific Clinical Research Management Group
    Upland, California
    Site status: Not listed — confirm with the team
  • CNS Healthcare
    Jacksonville, Florida
    Site status: Not listed — confirm with the team
  • Combined Research Orlando
    Orlando, Florida
    Site status: Not listed — confirm with the team
  • K2 Medical Research, LLC
    Tampa, Florida
    Site status: Not listed — confirm with the team
  • CenExel iResearch Atlanta
    Atlanta, Georgia
    Site status: Not listed — confirm with the team
  • Advanced Discovery Research LLC
    Atlanta, Georgia
    Site status: Not listed — confirm with the team
  • NeuroTrials Research, Inc.
    Atlanta, Georgia
    Site status: Not listed — confirm with the team
  • CenExel iResearch Savannah
    Savannah, Georgia
    Site status: Not listed — confirm with the team
  • Uptown Research Institute, LLC
    Chicago, Illinois
    Site status: Not listed — confirm with the team
  • American Medical Research, Inc.
    Warrenville, Illinois
    Site status: Not listed — confirm with the team
  • Copley Clinical
    Boston, Massachusetts
    Site status: Not listed — confirm with the team
  • Boston Clinical Trials
    Boston, Massachusetts
    Site status: Not listed — confirm with the team
  • Adams Clinical
    Watertown, Massachusetts
    Site status: Not listed — confirm with the team
  • Midwest Research Group
    Saint Charles, Missouri
    Site status: Not listed — confirm with the team
  • Center for Emotional Fitness Site
    Cherry Hill, New Jersey
    Site status: Not listed — confirm with the team
  • CenExel Hassman Research Institute
    Marlton, New Jersey
    Site status: Not listed — confirm with the team
  • Social Psychiatry Research Institute
    Brooklyn, New York
    Site status: Not listed — confirm with the team
  • Neurobehavioral Research, Inc.
    Cedarhurst, New York
    Site status: Not listed — confirm with the team
  • Bioscience Research, LLC
    Mount Kisco, 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
    New York, New York
    Site status: Not listed — confirm with the team
  • The Medical Research Network, L.L.C
    New York, New York
    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
  • Paradigm Research Professionals, LLP
    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
  • Psychiatry and Psychotherapy Partners Austin
    Austin, Texas
    Site status: Not listed — confirm with the team
  • FutureSearch Trials of Dallas, LP
    Dallas, Texas
    Site status: Not listed — confirm with the team
  • Cedar Clinical Research, Inc.
    Draper, Utah
    Site status: Not listed — confirm with the team

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Study ID: NCT05729373. 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 anxiety. 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 anxiety; 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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