This study looks at how a medicine called cariprazine helps kids aged 10-17 with bipolar I disorder. Bipolar disorder is a condition causing extreme mood swings. The study aims to see if cariprazine can make these mood swings less severe and check for any side effects. Cariprazine is already used for adults with similar problems.
Participants will be randomly assigned to two groups: one will get cariprazine, and the other will get a placebo, which is a harmless pill. Around 380 kids will join this study, taking place in about 60 locations globally. The study lasts several weeks, and kids might get different doses based on their age and weight. If the initial dose isn't working, doctors may increase it.
Participants will visit the hospital or clinic weekly for check-ups, which include medical tests and questionnaires. There might be more visits than usual care. The study will also include a 4-week safety check after treatment ends.
- Length: Several weeks with weekly hospital visits.
- Participants: Children aged 10-17 with bipolar I disorder.
- Groups: Randomly assigned to either cariprazine or placebo.