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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.

Recruiting
10-17 years
Both
Phase 3

Bipolar disorder is a mood problem that affects kids and adults. This study looks at a medicine called **cariprazine** for treating depression in kids aged 10-17 with bipolar I disorder. Cariprazine is already used for adults. In this study, doctors will divide participants into two groups: one gets the real medicine, and the other gets a placebo, which is a fake pill. About 380 kids will join from around the world. Depending on their age and weight, kids will get different doses. If the medicine isn’t working well after three weeks, the dose might be increased. Kids will have weekly check-ups at the clinic, which may include medical tests, blood tests, and filling out questionnaires. The study will last a few months, followed by four weeks of safety checks.

  • Frequent weekly visits to the hospital or clinic are required.
  • There is a 50% chance of receiving a placebo instead of the actual medicine.
  • Close monitoring for side effects and changes in mood is part of the study.
Study details
    Depression
    Bipolar I Disorder

NCT04777357

AbbVie

8 July 2024

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