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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 disorder.

Recruiting
10-17 years
All
Phase 3

This study looks at how well a drug called **Cariprazine** works for kids and teens aged 10 to 17 with Bipolar I Disorder, especially during depressive episodes. Bipolar I Disorder is a condition where mood changes from feeling very high (mania) to very low (depression). Cariprazine is already used for adults with this condition. In this study, participants will get either Cariprazine or a placebo (a pill without active medicine).

Participants will have regular check-ups at the hospital or clinic every week, where doctors will do health checks, blood tests, and ask questions about how they feel. The study includes a treatment period and then a check-up period for 4 more weeks to make sure everyone stays safe.

  • Participants might face more visits and tests compared to their usual treatment.
  • Study lasts several weeks, including regular hospital or clinic visits.
  • Participants have a 50% chance of receiving Cariprazine or a placebo.
Study details
    Depression
    Bipolar I Disorder

NCT04777357

AbbVie

8 July 2024

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