CompletedNCT04092686
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
Researchers compared SEP-363856 75mg, SEP-363856 100mg and placebo to find out how the approaches affected psychotic symptoms in people with schizophrenia.
Medication studyAges 18–65Multiple countries
Understand this study
What did researchers investigate?
Researchers compared SEP-363856 75mg, SEP-363856 100mg and placebo to find out how the approaches affected psychotic symptoms in people with schizophrenia.
Who was this study for?
This study was for people with schizophrenia. Listed age limits: 18 years to 65 years. Other eligibility criteria applied.
- Listed locations
- Rogers and 52 more locationsSee all locations and recruitment
- Study phase
- Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Study information
Study start dateStarted: October 14, 2019
- Recruitment status
- Completed
- Enrollment listed in the registry
- 464
- 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, Croatia, ...
- Age range
- From 18 Years to 65 Years
- Official registry ID
- NCT04092686
- Official title
Show the full official title
A Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Subjects With Schizophrenia
Recruitment & locations
CompletedRogers, United States · Anaheim, United States · Bellflower, United States
43 more locations
- Culver City, United States
- Long Beach, United States
- San Diego, United States
- Sherman Oaks, United States
- Hollywood, United States
- Miami Springs, United States
- Atlanta, United States
- Decatur, United States
- Chicago, United States
- Lake Charles, United States
- Gaithersburg, United States
- St Louis, United States
- Marlton, United States
- New York, United States
- Richardson, United States
- Burgas, Bulgaria
- Kardzhali, Bulgaria
- Novi Iskar, Bulgaria
- Plovdiv, Bulgaria
- Sofia, Bulgaria
- Zagreb, Croatia
- Daugavpils, Latvia
- Riga, Latvia
- Strenči, Latvia
- Arkhangelsk, Russia
- Engel's, Russia
- Moscow, Russia
- Saint Petersburg, Russia
- Saratov, Russia
- Stavropol, Russia
- Tomsk, Russia
- Belgrade, Serbia
- Kovin, Serbia
- Kragujevac, Serbia
- Niš, Serbia
- Novi Kneževac, Serbia
- Vršac, Serbia
- Kharkiv, Ukraine
- Kherson, Ukraine
- Kyiv, Ukraine
- Lviv, Ukraine
- Vinnytsia, Ukraine
- Russia
Questions about this study
What did researchers investigate?
Researchers compared SEP-363856 75mg, SEP-363856 100mg and placebo to find out how the approaches affected psychotic symptoms in people with schizophrenia.
Who is behind this study?
The study sponsor is Otsuka Pharmaceutical Development & Commercialization, Inc., a pharmaceutical company.
Did this study involve medication?
Yes. The study involved medication, including SEP-363856 75mg, SEP-363856 100mg and Placebo.
Who was this study for?
This study was for people with schizophrenia. Listed age limits: 18 years to 65 years. Other eligibility criteria applied.
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