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Study ID: NCT02969369. We help you review the study, but cannot decide medical eligibility.
CompletedNCT02969369
Safety study of Efficacy, Safety, and Tolerability of SEP-363856 in Parkinson Disease Psychosis
This study is completed in the United States. It is testing Efficacy, Safety, and Tolerability of SEP-363856 for Parkinson Disease Psychosis.
SchizophreniaDrugFrom 55 Years to 105 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.
United States · 24 sites
- Neuuro-Pain Medical CenterFresno, CaliforniaSite status: Not listed — confirm with the team
- Keck School of Medicine of USC/ University of Southern CaliforniaLos Angeles, CaliforniaSite status: Not listed — confirm with the team
- CiTrialsRiverside, CaliforniaSite status: Not listed — confirm with the team
- Georgetown University Hospial, Research Pharmacy ServciesWashington D.C., District of ColumbiaSite status: Not listed — confirm with the team
- JEM Research InstituteAtlantis, FloridaSite status: Not listed — confirm with the team
- UHealth at Boca RatonBoca Raton, FloridaSite status: Not listed — confirm with the team
- Parkinson's Disease and Movement Disorders Center of Boca RatonBoca Raton, FloridaSite status: Not listed — confirm with the team
- University of Miami, Dept. of NeurologyMiami, FloridaSite status: Not listed — confirm with the team
- Compass ResearchOrlando, FloridaSite status: Not listed — confirm with the team
- Neurology Associates of Ormond BeachOrmond Beach, FloridaSite status: Not listed — confirm with the team
- Parkinson's Disease Treatment Center of Southwest FloridaPort Charlotte, FloridaSite status: Not listed — confirm with the team
- Suncoast Neuroscience Associates, Inc.St. Petersburg, FloridaSite status: Not listed — confirm with the team
- University of Florida Parkinson's Disease and Movement Disorder's CenterTampa, FloridaSite status: Not listed — confirm with the team
- The Emory ClinicAtlanta, GeorgiaSite status: Not listed — confirm with the team
- Rush University Medical CenterChicago, IllinoisSite status: Not listed — confirm with the team
- University of Kansas Medical CenterKansas City, KansasSite status: Not listed — confirm with the team
- Henry Ford West Bloomfield HospitalWest Bloomfield, MichiganSite status: Not listed — confirm with the team
- Washington University School of MedicineSt Louis, MissouriSite status: Not listed — confirm with the team
- Icahn School of Medicine at Mount SinaiNew York, New YorkSite status: Not listed — confirm with the team
- Brian MadduxCincinnati, OhioSite status: Not listed — confirm with the team
- The Movement Disorder Clinic of OklahomaTulsa, OklahomaSite status: Not listed — confirm with the team
- Thomas Jefferson UniversityPhiladelphia, PennsylvaniaSite status: Not listed — confirm with the team
- University of Pennsylvania, Department of NeurologyPhiladelphia, PennsylvaniaSite status: Not listed — confirm with the team
- Inland Northwest ResearchSpokane, WashingtonSite 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 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
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 31, 2016
- Recruitment status
- Completed
- Enrollment listed in the registry
- 39
- 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
- Age range
- From 55 Years to 105 Years
- Official registry ID
- NCT02969369
- Official title
- A Multicenter Randomized Double-blind Followed by an Open-label Extension Study to Evaluate the Efficacy, Safety, and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis
- Official source
- Official registry link
Want help reviewing this study?
Study ID: NCT02969369. 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 capsule. 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 55 Years to 105 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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