Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients

This study is looking at the effects of **Lumateperone**, a medicine, in children aged 10-17 who have bipolar depression. Bipolar disorder is a mental health condition that causes extreme mood swings, including depressive episodes. The study will take place in multiple locations and has three parts: a Screening Period (up to 2 weeks) to check if you can join, a Treatment Period (6 weeks) where you may get Lumateperone or a fake pill (placebo), and a Safety Follow-up Period (1 week) to ensure you're okay after treatment.

• You must attend clinic visits during all phases of the study.
• Participants will not know if they are receiving Lumateperone or placebo.
• All participants' safety will be closely monitored.

To join, you need permission from your parent or guardian, and you must have bipolar disorder with recent depression. You can’t join if you have another main psychiatric condition, except ADHD, or if there's a risk of harm to yourself or others. This study aims to find better ways to help young people with bipolar depression.