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A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.

Testing Cariprazine for depression in kids with Bipolar I (ages 10-17).

Recruiting
10-17 years
All
Phase 3
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study is for kids aged 10-17 with bipolar I disorder, a mood disorder that causes intense emotional states. The drug being tested is called Cariprazine, which is approved for adults but not yet for kids. Participants will be randomly placed into one of two groups: one receiving the drug and the other receiving a placebo, a harmless pill with no medicine. The trial involves weekly hospital or clinic visits, where doctors will check the effectiveness of the treatment through medical tests, questionnaires, and blood tests.

About 380 kids will join this study across 60 locations worldwide. Participants will start with a specific dose, which may be increased if the initial results aren't strong enough. After the treatment, there will be a 4-week period to ensure safety.

  • The study involves regular weekly doctor visits.
  • Participants have a 50% chance to receive the actual drug.
  • Parents should consider the time commitment and possible side effects.
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Study details
    Depression
    Bipolar I Disorder

NCT04777357

AbbVie

12 April 2025

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