This study checks if lumateperone, a medicine, is safe for kids with schizophrenia or bipolar disorder. The trial lasts 26 weeks and involves taking lumateperone daily. Kids aged 10-17 with diagnosed conditions can join. The study includes a 2-week screening to see if they qualify, a 26-week treatment period, and a 2-week follow-up after treatment ends.
Schizophrenia is a mental disorder affecting how a person thinks and feels, while bipolar disorder causes extreme mood swings. This study is open-label, meaning everyone knows what medication is being given. To join, the child’s parent or guardian must give permission, and the child must agree too.
- The study lasts 26 weeks with regular clinic visits.
- All participants receive the same medication daily.
- Participants and their families must be aware of the potential risks, including mental health changes.
Children with other primary psychiatric disorders or those who pose a risk to themselves or others may not join. The study aims to ensure the medicine is safe and well-tolerated in young patients.