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CompletedNCT06462612

Lumateperone study for mania in bipolarity

About this titleRead the official source — NCT06462612

Researchers compared Lumateperone and placebo to find out how the approaches affected manic symptoms in people with bipolarity type I during a manic episode.

Medication studyAges 18–75Multiple countries
The study in practice

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.

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Study clarity

Study information

Study start dateStarted: July 17, 2024
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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Recruitment & locations

Completed

Bentonville, United States · Little Rock, United States · Anaheim, United States

28 more locations
  • Cerritos, United States
  • 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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FAQ

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.

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