RecruitingNCT06372964
Lumateperone or placebo for depression symptoms in young people with bipolarity
About this title
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Read the official source — NCT06372964Researchers are comparing Lumateperone and placebo, tracking side effects to assess safety in children with bipolarity type II during a depressive episode.
Medication studyAges 10–17Multiple countries
Understand this study
What is this study about?
Researchers are comparing Lumateperone and placebo, tracking side effects to assess safety in children with bipolarity type II during a depressive episode.
Who could participate?
This study is for people with bipolarity. Listed age limits: 10 years to 17 years. Other eligibility criteria apply.
- Listed locations
- Dothan and 67 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: May 14, 2024
- Recruitment status
- Recruiting
- Enrollment listed in the registry
- 384
- 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, Colombia, India, ...
- Age range
- From 10 Years to 17 Years
- Official registry ID
- NCT06372964
- Official title
Show the full official title
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lumateperone for the Treatment of Major Depressive Episodes (MDEs) Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) in Pediatric Patients Aged 10 to 17 Years
Recruitment & locations
Currently recruitingA study may be recruiting, but some locations may no longer be accepting participants. Confirm availability with the research team.
Dothan, United States · Little Rock, United States · Anaheim, United States
48 more locations
- Redlands, United States
- Sacramento, United States
- San Diego, United States
- West Covina, United States
- Colorado Springs, United States
- Fort Myers, United States
- Hialeah, United States
- Homestead, United States
- Miami, United States
- Miami Gardens, United States
- Miami Lakes, United States
- Orlando, United States
- West Palm Beach, United States
- Atlanta, United States
- Lawrenceville, United States
- Savannah, United States
- Chicago, United States
- Elgin, United States
- Indianapolis, United States
- Baltimore, United States
- Bloomfield Hills, United States
- Saint Charles, United States
- St Louis, United States
- Lincoln, United States
- New York, United States
- Avon Lake, United States
- Cincinnati, United States
- Garfield Heights, United States
- Westlake, United States
- Oklahoma City, United States
- Austin, United States
- Beaumont, United States
- Flower Mound, United States
- Houston, United States
- Richmond, United States
- Bellevue, United States
- Everett, United States
- Barranquilla, Colombia
- Bello, Colombia
- Bogotá, Colombia
- Pereira, Colombia
- Ahmedabad, India
- Chhatrapati Sambhajinagar, India
- Nashik, India
- Varanasi, India
- Belgrade, Serbia
- Niš, Serbia
- Novi Sad, Serbia
Interested in joining this study?
Questions about this study
What is this study about?
Researchers are comparing Lumateperone and placebo, tracking side effects to assess safety in children with bipolarity type II during a depressive episode.
Who is behind this study?
The study sponsor is Intra-Cellular Therapies, Inc.
Does this study involve medication?
Yes. The study involves medication, including Lumateperone and Placebo.
Who can participate?
This study is for people with bipolarity. Listed age limits: 10 years to 17 years. Other eligibility criteria apply.
Is this study still recruiting?
The registry lists this study as recruiting.
