Lumateperone study for mania in bipolarity
About this title
Read the official source — NCT06462612Researchers compared Lumateperone and placebo to find out how the approaches affected manic symptoms in people with bipolarity type I during a manic episode.
Understand this study
What did researchers investigate?
Researchers compared Lumateperone 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?
This study was for people with bipolarity. Listed age limits: 18 years to 75 years. Other eligibility criteria applied.
- Listed locations
- Bentonville and 34 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
- Recruitment status
- Completed
- Enrollment listed in the registry
- 351
- Sponsor
- Intra-Cellular Therapies, Inc.
- Sponsor type
- Other organization
- Study type
- Drug
- Intervention type
- Drug
- Study phase
- Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
- Locations
- United States, Bulgaria, Romania, ...
- Age range
- From 18 Years to 75 Years
- Official registry ID
- NCT06462612
- Official title
Show the full official title
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients With Manic Episodes or Manic Episodes With Mixed Features Associated With Bipolar I Disorder (Bipolar Mania)
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Explore recruiting studiesRecruitment & locations
Bentonville, United States · Little Rock, United States · Anaheim, United States
28 more locations
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- Orange, United States
- Torrance, United States
- Hialeah, United States
- Miami, United States
- Miami Lakes, United States
- Tampa, United States
- West Palm Beach, United States
- Atlanta, United States
- Stockbridge, United States
- Chicago, United States
- Gaithersburg, United States
- Glen Oaks, United States
- Cincinnati, United States
- Richardson, United States
- Burgas, Bulgaria
- Kazanlak, Bulgaria
- Plovdiv, Bulgaria
- Sliven, Bulgaria
- Sofia, Bulgaria
- Brasov, Romania
- Bucharest, Romania
- Iași, Romania
- Belgrade, Serbia
- Kovin, Serbia
- Kragujevac, Serbia
- Niš, Serbia
- Novi Kneževac, Serbia
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Questions about this study
What did researchers investigate?
Researchers compared Lumateperone 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 Intra-Cellular Therapies, Inc.
Did this study involve medication?
Yes. The study involved medication, including Lumateperone and Placebo.
Who was this study for?
This study was for people with bipolarity. Listed age limits: 18 years to 75 years. Other eligibility criteria applied.
