This research study is looking at whether an investigational medication can help reduce symptoms of depression in children and teens with bipolar disorder who are experiencing a depressive episode.

The United States Food and Drug Administration (FDA) has approved the study drug (called CAPLYTA®) for the treatment of bipolar depression in adults. However, the study drug is not approved for the treatment of children and teenagers with bipolar depression. This research will help determine whether it is effective in children and teens.

You or your child may be eligible for this study if you meet the following criteria.

Inclusion Criteria:

• Ages 10 to 17
• Diagnosed with bipolar I or II disorder
• Currently in a major depressive episode
• Have had at least one manic or hypomanic episode in your lifetime
• Able to swallow capsules
• Willing to discontinue all antipsychotic medications, mood stabilizers (lithium, valproate, carbamazepine), and antidepressants
• Have a parent or legal guardian able to attend all visits

Exclusion Criteria:

• A primary psychiatric diagnosis other than bipolar I or II disorder (ADHD is allowed)
• Hospitalized for a manic episode in the past 30 days
• Certain therapies (ECT, vagal nerve stimulation, or similar neuromodulation treatments) within the past 6 months
• Use of certain sleep aids or benzodiazepines, or use of clozapine

Overall Duration

The first part of the study lasts 6 weeks, in which participants will receive either the study medication or a placebo. After that, participants have the option of rolling over into the open-label portion, where they are guaranteed to receive the study medication for 28 weeks.

Study Activities

• Weekly visits with site staff and a study-certified rater during the double-blind portion
• Clinical labs
• Tanner staging (a five-stage system doctors use to measure physical development and track a person’s progression through puberty)
• Mood assessments
• Pregnancy/drug testing

Other Details

• All visits conducted in person with the participant and their guardian
• Snacks provided, plus free blood work with results

Families may receive up to $560 for visits, plus up to $60 for travel per visit.

There is no cost for you/your child to participate in our research study.