CompletedNCT04115319

Safety study of SEP-363856 in schizophrenia

This study is completed in the United States, in Romania, in Russia, .... It is testing SEP-363856 for schizophrenia.

SchizophreniaDrugFrom 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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Study ID: NCT04115319. We help you review the study, but cannot decide medical eligibility.

Check recruitment and locations

Recruitment checked against the registry by HopeStage on 15 September 2026. Registry information can change. Always confirm availability with the research team.

Check the official registry

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

Romania · 5 sites

Research Site
Brasov
Site status: Not listed — confirm with the team
Research Site
Bucharest
Site status: Not listed — confirm with the team
Research Site
Bucharest
Site status: Not listed — confirm with the team
Research Site
Bucharest
Site status: Not listed — confirm with the team
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Iași
Site status: Not listed — confirm with the team

Russia · 13 sites

Research Site
Arkhangelsk
Site status: Not listed — confirm with the team
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Moscow
Site status: Not listed — confirm with the team
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Omsk
Site status: Not listed — confirm with the team
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Saint Petersburg
Site status: Not listed — confirm with the team
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Saint Petersburg
Site status: Not listed — confirm with the team
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Saint Petersburg
Site status: Not listed — confirm with the team
Research Site
Saint Petersburg
Site status: Not listed — confirm with the team
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Saint Petersburg
Site status: Not listed — confirm with the team
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Smolensk
Site status: Not listed — confirm with the team
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Stavropol
Site status: Not listed — confirm with the team
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Tomsk
Site status: Not listed — confirm with the team
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Yaroslavl
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Yekaterinburg
Site status: Not listed — confirm with the team

Ukraine · 6 sites

Research Site
Ivano-Frankivsk
Site status: Not listed — confirm with the team
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Kharkiv
Site status: Not listed — confirm with the team
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Kyiv
Site status: Not listed — confirm with the team
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Smila
Site status: Not listed — confirm with the team
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Ternopil
Site status: Not listed — confirm with the team
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Uzhhorod
Site status: Not listed — confirm with the team

United States · 18 sites

Research Site
Cerritos, California
Site status: Not listed — confirm with the team
Research Site
Oakland, California
Site status: Not listed — confirm with the team
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Oceanside, California
Site status: Not listed — confirm with the team
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San Diego, California
Site status: Not listed — confirm with the team
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Torrance, California
Site status: Not listed — confirm with the team
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Miami, Florida
Site status: Not listed — confirm with the team
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Miami Lakes, Florida
Site status: Not listed — confirm with the team
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Atlanta, Georgia
Site status: Not listed — confirm with the team
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Hoffman Estates, Illinois
Site status: Not listed — confirm with the team
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Lincolnwood, Illinois
Site status: Not listed — confirm with the team
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Shreveport, Louisiana
Site status: Not listed — confirm with the team
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St Louis, Missouri
Site status: Not listed — confirm with the team
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Las Vegas, Nevada
Site status: Not listed — confirm with the team
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Cedarhurst, New York
Site status: Not listed — confirm with the team
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Jamaica, New York
Site status: Not listed — confirm with the team
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Rochester, New York
Site status: Not listed — confirm with the team
Research Site
Charlotte, North Carolina
Site status: Not listed — confirm with the team
Research Site
North Canton, Ohio
Site status: Not listed — confirm with the team

In plain English

Key information made simple

What is this study testing?

This study is testing whether the Long-term Safety and Tolerability of an Investigational Drug may be useful for adults experiencing schizophrenia.

What would participation involve?

Participants may receive the Long-term Safety and Tolerability of 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 Romania, in Russia, and in Ukraine.

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.

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

What are the exact eligibility criteria, and what could exclude someone?
How many visits, assessments, or follow-ups are expected, and over what period?
What risks, side effects, practical burdens, or alternatives should be understood first?
Who should be contacted to confirm locations, timing, compensation, and next steps?

Study clarity

Things to check before joining

Study start dateStarted: November 21, 2019

Recruitment status: Completed
Enrollment listed in the registry: 305
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor type: Pharmaceutical company
Study type: Drug
Intervention type: Medication / drug
Study phase: Phase 3
Locations: United States, Romania, Russia, ...
Age range: From 18 Years to 65 Years
Official registry ID: NCT04115319
Official title: A Randomized, Double-blind, Active Comparator-Controlled Study to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia
Official source: Official registry link

Want help reviewing this study?

Study ID: NCT04115319. 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 SEP363856, quetiapine XR. 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 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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