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Study ID: NCT02969382. We help you review the study, but cannot decide medical eligibility.
CompletedNCT02969382
SEP-363856 for schizophrenia
This study is completed in the United States, in Hungary, in Romania, .... It is testing SEP-363856 for schizophrenia.
SchizophreniaDrugFrom 18 Years to 40 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.
Check recruitment and locations
Recruitment checked against the registry by HopeStage on . Registry information can change. Always confirm availability with the research team.
The overall study status can differ from each site's status. Open a country to see its locations and their registry status.
Hungary · 2 sites
- Rehabilitacios Elmegyogyaszati osztalyGyöngyösSite status: Not listed — confirm with the team
- Bekes Megyei Kozponti Korhaz Pandy Kalman TagkorhazaGyulaSite status: Not listed — confirm with the team
Romania · 4 sites
- BucharestBucharestSite status: Not listed — confirm with the team
- Centrul de Evaluare si Tratament al Toxicodependentelor pentru Tineri "Sfantul Stelian" - C.E.T.T.T. "Sf. Stelian"BucharestSite status: Not listed — confirm with the team
- Spitalul Clinic de Neuropsihiatrie CraiovaCraiovaSite status: Not listed — confirm with the team
- Institutul de Psihiatrie Socola Iasi, Sectia Clinica III Acuti, Sos. BuciumIașiSite status: Not listed — confirm with the team
Russia · 10 sites
- State Budgetary Institution of Republic Karelia "Republican Psychiatric Hospital"Matrosy, Republic KareliaSite status: Not listed — confirm with the team
- Federal State Budgetary Scientific Instittuion "Scientific Center of Mental HealthMoscowSite status: Not listed — confirm with the team
- Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital #1 named after P.P. Kashchenko"Saint PetersburgSite status: Not listed — confirm with the team
- City Psychiatric Hospital of St. Nikolay ChudotvoretsSaint PetersburgSite status: Not listed — confirm with the team
- FSBI Saint Petersburg Scientifc and Research Psychoneurological Instatitute named after V.M BekhterevSaint PetersburgSite status: Not listed — confirm with the team
- SPHI "City Mental Hospital #3 n.a. I.I.Skvortsov-Stepanov"Saint PetersburgSite status: Not listed — confirm with the team
- 300173524Saint PetersburgSite status: Not listed — confirm with the team
- 300151369SaratovSite status: Not listed — confirm with the team
- SBEI HPE "Smolensk State Medical University" of the MoH of the RFSmolenskSite status: Not listed — confirm with the team
- 300195230YekaterinburgSite status: Not listed — confirm with the team
Ukraine · 11 sites
- Ch of Psychiatry, Narcology and Med PsycholIvano-FrankivskSite status: Not listed — confirm with the team
- Dept of Crisis Cond & Primary Psych Episode #1Ivano-FrankivskSite status: Not listed — confirm with the team
- Psychiatric Department of Primary Psychotic EpisodesKharkivSite status: Not listed — confirm with the team
- Unit of Emergency Psychiatry and NarcologyKharkivSite status: Not listed — confirm with the team
- Dept of Psychiarty #3 (male) and #10 (female)KhersonSite status: Not listed — confirm with the team
- TMA Psychiatry in Kyiv Center of NT & Rehabilitation of Psychotic ConditionsKyivSite status: Not listed — confirm with the team
- CI Odesa Regional Medical Center of Mental HealthOdesaSite status: Not listed — confirm with the team
- Femal Dept #11, Male Dept #12SmilaSite status: Not listed — confirm with the team
- Ch of Neurology, Psychiatry, Narcology and MPTernopilSite status: Not listed — confirm with the team
- Dept of PsychiatryUzhhorodSite status: Not listed — confirm with the team
- Ch of Psychiatry and NarcologyVinnytsiaSite status: Not listed — confirm with the team
United States · 6 sites
- Woodland International Research GroupLittle Rock, ArkansasSite status: Not listed — confirm with the team
- Collaborative Neuroscience Network, LLCGarden Grove, CaliforniaSite status: Not listed — confirm with the team
- California Neuropsychopharmacology Clinical Research Institute-LA, LLC(CNRI- LA, LLC)Pico Rivera, CaliforniaSite status: Not listed — confirm with the team
- Atlanta Center for Medical ResearchAtlanta, GeorgiaSite status: Not listed — confirm with the team
- Lake Charles Clinical TrialsLake Charles, LouisianaSite status: Not listed — confirm with the team
- Pillar Clinical Research, LLCRichardson, TexasSite status: Not listed — confirm with the team
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 protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Hungary, in Romania, and in Russia.
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
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.
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?
Things to check before joining
Study start dateStarted: December 5, 2016
- Recruitment status
- Completed
- Enrollment listed in the registry
- 245
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Sponsor type
- Pharmaceutical company
- Study type
- Drug
- Intervention type
- Medication / drug
- Study phase
- Phase 2Usually explores whether the intervention may work, while continuing to monitor safety.
- Locations
- United States, Hungary, Romania, ...
- Age range
- From 18 Years to 40 Years
- Official registry ID
- NCT02969382
- Official title
- A 4-Week, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexibly-dosed, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adult Subjects With Schizophrenia
- Official source
- Official registry link
Want help reviewing this study?
Study ID: NCT02969382. We help you review the study, but cannot decide medical eligibility.
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.
Not medical advice
Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com
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 - Cap. 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 schizophrenia; age range: From 18 Years to 40 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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