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TerminatedNCT04109950
A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia
Researchers are studying SEP-363856, tracking side effects to assess safety and tolerability in people with schizophrenia.
Medication studyAges 13–65Multiple countries
Understand this study
What is this study about?
Researchers are studying SEP-363856, tracking side effects to assess safety and tolerability in people with schizophrenia.
Who could participate?
This study is for people with schizophrenia. Listed age limits: 13 years to 65 years. Other eligibility criteria apply.
- Listed locations
- Little Rock and 77 more locationsSee all locations and recruitment
- Study phase
- Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
What to know before participating
A point to clarify
This summary does not cover all risks or eligibility requirements. What risks or changes to my care would apply to me?
Things to check before joining
Study start dateStarted: November 20, 2019
- Recruitment status
- Terminated
- Enrollment listed in the registry
- 463
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- 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
- United States, Bulgaria, Colombia, ...
- Age range
- From 13 Years to 65 Years
- Official registry ID
- NCT04109950
- Official title
Show the full official title
An Open-label Extension Study to Assess the Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia
Recruitment & locations
TerminatedLittle Rock, United States · Rogers, United States · Anaheim, United States
59 more locations
- Culver City, United States
- Lemon Grove, United States
- Long Beach, United States
- Montclair, United States
- San Diego, United States
- Sherman Oaks, United States
- Miami Springs, United States
- Oakland Park, United States
- Atlanta, United States
- Decatur, United States
- Lake Charles, United States
- Gaithersburg, United States
- Flowood, United States
- St Louis, United States
- Marlton, United States
- New York, United States
- Dayton, United States
- Austin, United States
- Richardson, United States
- Burgas, Bulgaria
- Kardzhali, Bulgaria
- Novi Iskar, Bulgaria
- Pazardzhik, Bulgaria
- Pleven, Bulgaria
- Sofia, Bulgaria
- Veliko Tarnovo, Bulgaria
- Vratsa, Bulgaria
- Barranquilla, Colombia
- Bogotá, Colombia
- Zagreb, Croatia
- Daugavpils, Latvia
- Riga, Latvia
- Strenči, Latvia
- Chelyabinsk, Russia
- Matrosy, Russia
- Moscow, Russia
- Nizhny Novgorod, Russia
- Saint Petersburg, Russia
- Samara, Russia
- Saratov, Russia
- Stavropol, Russia
- Talagi, Russia
- Belgrade, Serbia
- Gornja Toponica, Serbia
- Kovin, Serbia
- Kragujevac, Serbia
- Niš, Serbia
- Novi Kneževac, Serbia
- Novi Sad, Serbia
- Vršac, Serbia
- Ivano-Frankivsk, Ukraine
- Kharkiv, Ukraine
- Kherson, Ukraine
- Kyiv, Ukraine
- Lviv, Ukraine
- Nove, Ukraine
- Odesa, Ukraine
- Vinnytsia, Ukraine
- Russia
A listed location does not confirm current availability.
Questions about this study
What is this study about?
Researchers are studying SEP-363856, tracking side effects to assess safety and tolerability in people with schizophrenia.
Who is behind this study?
The study sponsor is Otsuka Pharmaceutical Development & Commercialization, Inc., a pharmaceutical company.
Does this study involve medication?
Yes. The study involves medication, including SEP-363856.
Who can participate?
This study is for people with schizophrenia. Listed age limits: 13 years to 65 years. Other eligibility criteria apply.
Is this study still recruiting?
The registry lists this study as terminated.
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