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RecruitingNCT06894212

SEP-363856 for schizophrenia

The registry lists this study as recruiting. Study locations are listed in the United States and in Japan. Confirm recruitment at each site. It is testing SEP-363856 for schizophrenia.

SchizophreniaDrugFrom 18 Years to 65 Years
In plain English

Key information made simple

What is this study testing?

This study is testing whether the Efficacy and Safety of SEP-363856 may be useful for adults experiencing schizophrenia.

What would participation involve?

Participants may receive the Efficacy and Safety of 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 Japan and in the United States.

Who is it mainly for?

This study appears to be mainly for adults with schizophrenia.

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: February 28, 2025
Recruitment status
Recruiting
Enrollment listed in the registry
522
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor type
Pharmaceutical company
Study type
Drug
Intervention type
Medication / drug, OTHER
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Locations
United States, Japan
Age range
From 18 Years to 65 Years
Official registry ID
NCT06894212
Official title
A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia

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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.

Japan · 38 sites
  • Hotei Hospital
    Konan-shi, Aichi-ken
    Site status: Recruiting
  • Seishinkai Okehazama Hospital
    Toyoake-shi, Aichi-ken
    Site status: Recruiting
  • Seijinkai Seinan Hospital
    Hachinohe-shi, Aomori
    Site status: Recruiting
  • National Hospital Organization Shimofusa Psychiatric Medical Center
    Chiba, Chiba
    Site status: Recruiting
  • National Kohnodai Medical Center
    Ichikawa-shi, Chiba
    Site status: Recruiting
  • Fukuoka University Hospital
    Fukuoka, Fukuoka
    Site status: Recruiting
  • Kuramitsu Hospital
    Fukuoka, Fukuoka
    Site status: Recruiting
  • National Hospital Organization Kokura Medical Center Site
    Kokuraminami-ku, Kitakyushu-shi, Fukuoka
    Site status: Recruiting
  • Shiranui Hospital
    Omuta-shi, Fukuoka
    Site status: Recruiting
  • Social Medical Corporation Asaka Hospital
    Kōriyama, Fukushima
    Site status: Recruiting
  • Hayakawa Clinic
    Kure, Hiroshima
    Site status: Recruiting
  • NHO Kure Medical Center
    Kure-shi, Hiroshima
    Site status: Recruiting
  • Nayoro City General Hospital
    Nayoro-shi, Hokkaido
    Site status: Recruiting
  • Obihiro Kosei Hospital
    Obihiro, Hokkaido
    Site status: Recruiting
  • Goryokai Medical Corporation Hospital
    Sapporo, Hokkaido
    Site status: Recruiting
  • Iwate Medical University Hospital
    Shiwa-gun, Iwate
    Site status: Recruiting
  • Hatano Kousei Hospital
    Hadano-shi, Kanagawa
    Site status: Recruiting
  • Tanzawa Hospital
    Hadano-shi, Kanagawa
    Site status: Recruiting
  • Fujimidai Hospital Site
    Hiratsuka-shi, Kanagawa
    Site status: Recruiting
  • Yokohama Hino Hospital
    Yokohama, Kanagawa
    Site status: Recruiting
  • Yuge Hospital
    Kumamoto, Kumamoto
    Site status: Recruiting
  • Miyakonojo Shinsei Hospital
    Miyakonojo-shi, Miyazaki
    Site status: Recruiting
  • Kansai Medical University Medical Center
    Moriguchi-shi, Osaka
    Site status: Recruiting
  • Neyagawa Sanatorium
    Neyagawa, Osaka
    Site status: Recruiting
  • National Hospital Organization Hizen Psychiatric Medical Center Site
    Kanzaki-gun, Saga-ken
    Site status: Recruiting
  • Rainbow and Sea Hospital
    Karatsu-shi, Saga-ken
    Site status: Recruiting
  • Inuo Hospital
    Tosu-shi, Saga-ken
    Site status: Recruiting
  • Shiga University of Medical Science Hospital
    Ōtsu, Shiga
    Site status: Recruiting
  • Dokkyo Medical University Hospital
    Shimotsuga-gun, Tochigi
    Site status: Recruiting
  • Jichi Medical University Hospital
    Shimotsuke-Shi, Tochigi
    Site status: Recruiting
  • Tochigi Prefectural Okamotodai Hospital
    Utsunomiya, Tochigi
    Site status: Recruiting
  • National Center of Neurology and Psychiatry
    Kodaira-shi, Tokyo
    Site status: Recruiting
  • Asuka Hospital
    Machida-shi, Tokyo
    Site status: Recruiting
  • Showa Medical University Karasuyama Hospital
    Setagaya-ku, Tokyo
    Site status: Recruiting
  • Toyama Prefectural Center Hospital
    Toyama, Toyama
    Site status: Recruiting
  • Sanyo Hospital
    Sakata-shi, Yamagata
    Site status: Recruiting
  • Yamagata Sakuracho Hospital Site
    Yamagata, Yamagata
    Site status: Recruiting
  • Wakayama Medical University Hospital
    Wakayama
    Site status: Recruiting
United States · 35 sites
  • Pillar Clinical Research LLC - Bentonville Site
    Bentonville, Arkansas
    Site status: Active Not Recruiting
  • Pillar Clinical Research (Little Rock AR) Site
    Little Rock, Arkansas
    Site status: Active Not Recruiting
  • Woodland International Research Group Site
    Little Rock, Arkansas
    Site status: Active Not Recruiting
  • Woodland Research Northwest Site
    Rogers, Arkansas
    Site status: Active Not Recruiting
  • Clinical Innovations, Inc. dba CITrials (Bellflower)
    Bellflower, California
    Site status: Active Not Recruiting
  • ProScience Research Group Site
    Culver City, California
    Site status: Active Not Recruiting
  • CenExel CNS - Garden Grove (Collaborative Neuroscience Research) Site
    Garden Grove, California
    Site status: Active Not Recruiting
  • Synergy San Diego Site
    Lemon Grove, California
    Site status: Withdrawn
  • Catalina Research Institute Site
    Montclair, California
    Site status: Active Not Recruiting
  • Clinical Innovations Inc. DBA CITrials (Riverside)
    Riverside, California
    Site status: Completed
  • Richmond Behavioral Associates LLC
    Riverside, California
    Site status: Active Not Recruiting
  • CNRI - San Diego LLC Site
    San Diego, California
    Site status: Active Not Recruiting
  • Schuster Medical Research Institute
    Sherman Oaks, California
    Site status: Active Not Recruiting
  • CenExel CNS - Los Alamitos (Collaborative Neuroscience Research)
    Torrance, California
    Site status: Active Not Recruiting
  • Galiz Research Site
    Hialeah, Florida
    Site status: Active Not Recruiting
  • Segal Trials - Larkin Behavioral Health - Inpatient & Early Phase Site
    Hollywood, Florida
    Site status: Active Not Recruiting
  • Cenexel RCA (Research Centers of America) Site
    Hollywood, Florida
    Site status: Active Not Recruiting
  • Premier Clinical Research Institute
    Miami, Florida
    Site status: Active Not Recruiting
  • D & H National Research Centers NC
    Miami, Florida
    Site status: Active Not Recruiting
  • Innovative Clinical Research, Inc. Site
    Miami Lakes, Florida
    Site status: Active Not Recruiting
  • Health Synergy Clinical Research LLC Site
    West Palm Beach, Florida
    Site status: Active Not Recruiting
  • Synexus Clinical Research US Inc - Atlanta
    Atlanta, Georgia
    Site status: Active Not Recruiting
  • CenExel ACMR (Atlanta Center for Medical Research, LLC) Site
    Atlanta, Georgia
    Site status: Active Not Recruiting
  • CenExel IRA (CenExcel iResearch, LLC) Site
    Decatur, Georgia
    Site status: Active Not Recruiting
  • Accelerated Clinical Trials in Peachtree Corners GA Site
    Peachtree Corners, Georgia
    Site status: Active Not Recruiting
  • Uptown Research Institute
    Chicago, Illinois
    Site status: Active Not Recruiting
  • Pillar Clinical Research LLC (Chicago)
    Chicago, Illinois
    Site status: Active Not Recruiting
  • Eastern Clinical Research Associates
    New Orleans, Louisiana
    Site status: Active Not Recruiting
  • Cenexel CBH (CBH Health)
    Gaithersburg, Maryland
    Site status: Active Not Recruiting
  • Hassman Research Institute, LLC
    Marlton, New Jersey
    Site status: Active Not Recruiting
  • Neuro-Behavioral Clinical Research Site
    North Canton, Ohio
    Site status: Active Not Recruiting
  • Community Clinical Research Inc
    Austin, Texas
    Site status: Active Not Recruiting
  • InSite Clinical Research
    DeSoto, Texas
    Site status: Active Not Recruiting
  • HD Research - Memorial Hermann Surgery Center Memorial Village
    Houston, Texas
    Site status: Active Not Recruiting
  • Pillar Clinical Research LLC (Richardson, TX) Site
    Richardson, Texas
    Site status: Active Not Recruiting
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 schizophrenia. 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 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 schizophrenia; 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 recruiting. Individual sites may have different statuses. The research team must confirm whether a site is open and whether you meet the criteria.

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