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RecruitingNCT07225712

Safety study of SEP-363856 in schizophrenia

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

SchizophreniaDrugOver 18 Years
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Check the official registry

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Japan · 1 site
  • Jimbo Kokorono Clinic
    Fukuoka
    Site status: Recruiting
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 schizophrenia.

What would participation involve?

Participants may receive SEP-363856, attend study visits with the research team. The registry lists locations in Japan.

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 a comparison group, how many visits or travel steps are needed, the exact eligibility criteria.

What to expect

Your next step

Study sites are listed in the registry. Recruitment status can differ between sites. Ask the research team to confirm the location, any in-person visits, time commitment, costs or compensation, and participation criteria.

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: December 22, 2025
Recruitment status
Recruiting
Enrollment listed in the registry
100
Sponsor
Otsuka Pharmaceutical Co., Ltd.
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
Japan
Age range
Over 18 Years
Official registry ID
NCT07225712
Official title
A Multicenter, Uncontrolled, Open-label Trial to Evaluate the Tolerability, Safety, and Efficacy of Long-term Administration of SEP-363856 in Patients With Schizophrenia
Official source
Official registry link

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Study ID: NCT07225712. 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 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. 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: Over 18 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 Co., Ltd., 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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