CompletedNCT03259555
A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute manic episodes Associated With Bipolarity type I
Researchers compared Brexpiprazole and placebo to find out how the approaches affected manic symptoms in people with bipolarity type I during a manic episode.
Medication studyAges 18–65Multiple countries
Understand this study
What did researchers investigate?
Researchers compared Brexpiprazole and placebo to find out how the approaches affected manic symptoms in people with bipolarity type I during a manic episode.
Who was this study for?
Listed age limits: 18 years to 65 years.
- Listed locations
- Little Rock and 47 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: September 14, 2017
- Recruitment status
- Completed
- Enrollment listed in the registry
- 322
- 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, Poland, ...
- Age range
- From 18 Years to 65 Years
- Official registry ID
- NCT03259555
- Official title
Show the full official title
A Multicenter, Randomized, Double-blind Trial of Brexpiprazole Versus Placebo for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder
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Recruitment & locations
CompletedLittle Rock, United States · Rogers, United States · Culver City, United States
40 more locations
- Garden Grove, United States
- Glendale, United States
- Oakland, United States
- Orange, United States
- Panorama City, United States
- Riverside, United States
- San Diego, United States
- Hialeah, United States
- Homestead, United States
- Largo, United States
- Miami, United States
- North Miami, United States
- Atlanta, United States
- Hoffman Estates, United States
- Gaithersburg, United States
- St Louis, United States
- Raleigh, United States
- Oklahoma City, United States
- Charleston, United States
- Austin, United States
- Garland, United States
- Richardson, United States
- Richland, United States
- Burgas, Bulgaria
- Kardzhali, Bulgaria
- Novi Iskar, Bulgaria
- Plovdiv, Bulgaria
- Rousse, Bulgaria
- Sofia, Bulgaria
- Targovishte, Bulgaria
- Veliko Tarnovo, Bulgaria
- Vratsa, Bulgaria
- Choroszcz, Poland
- Gdansk, Poland
- Poznan, Poland
- Tuszyn, Poland
- Belgrade, Serbia
- Kovin, Serbia
- Kragujevac, Serbia
- Novi Sad, Serbia
Questions about this study
What did researchers investigate?
Researchers compared Brexpiprazole and placebo to find out how the approaches affected manic symptoms in people with bipolarity type I during a manic episode.
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 Brexpiprazole and Placebo.
Who was this study for?
Listed age limits: 18 years to 65 years.
