Bipolar disorder is a serious mood problem that can make people feel very happy or very sad. In kids (10-17 years old), it hasn't been studied as much as in adults. This study is testing if a medicine called cariprazine can help kids with the sad episodes of bipolar I disorder. Cariprazine is already used for adults with this condition.
In the study, kids will be put into one of two groups: one gets the real medicine, and the other gets a placebo (a fake pill that doesn't do anything). About 380 kids will join from different places around the world. Based on their age and weight, they will get different doses of the medicine. If the medicine isn't working enough after three weeks, doctors might increase the dose. The study lasts a few weeks, with weekly visits to the doctor to check on how they're doing. After the treatment, there will be a 4-week safety follow-up.
- Study involves regular weekly doctor visits.
- Participants may receive a placebo, not the real medicine.
- There may be risks and extra burdens compared to normal treatment.