About the BALANCE Study

The purpose of this study is to evaluate the safety and efficacy of an investigational drug in children and adolescents with bipolar I disorder.

Bipolar I disorder can change the way a child or teen interacts with the world around them. If you or your child have bipolar I disorder and depression, we are inviting you to take part in the Balance Study for children and teens, aged 10 to 17 years of age, who have been struggling with bipolar I depression.

The Balance Study will enroll about 380 children and teens with bipolar I depression at participating study centers throughout North America. The study team will be able to further discuss whether you or your child are eligible for the study.

Participants who qualify to take part in the study may receive compensation for time and travel for study-related visits.

There is no cost to participate in the Balance Study.

If you or your child decide to take part:
- You or your child will receive study-related care throughout the study from a team of experienced doctors.
- All study-related visits, tests, and investigational drug will be provided at no cost to you or your child.

Who can participate in the BALANCE Study?

You or your child may be eligible to join the Balance study if you or they:
- Are 10 to 17 years old
- May have a diagnosis of bipolar I disorder, which can be confirmed at screening
- Have been having depression for at least the past couple of weeks: Depressive symptoms include feeling sad, down, or depressed, not enjoying things you usually do, suicidal thoughts, difficulty falling or staying asleep, loss of energy, and/or difficulty concentrating

What does the BALANCE Study involve?

The Balance Study will last for approximately 13 weeks. After completing 8 visits in the Balance Study, you may be able to participate in an open-label study. During your/your child's participation in the study, you will visit a study center within a short distance of your home for various tests, assessments, and checkups.

Before participating in the study, participants will first go through a screening process to see if they are eligible for the study. This will include thorough diagnostics related to bipolar I disorder. If they are eligible, participants will proceed to the 6-week study-treatment period where the investigational drug capsule or placebo will be taken by mouth at the same time daily. After the study-treatment period has been completed, there will be a follow-up period where the study staff will check in on your/your child's well-being.

The research team will be able to explain more about what the Balance Study will involve, and it is up to you or your child to decide if you want to take part.

Participation in this study is voluntary. Whether or not you decide to participate in this study will not affect your current or future relationships with your doctors. If you decide to participate, you are free to withdraw at any time without affecting those relationships.

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