The Balance Study Bipolar I depression can change the way a child or teen interacts with the world around them.

If you or your child have bipolar I depression, we are inviting you to take part in the Balance Study for children and adolescents, aged 10 to 17 years of age, who have been struggling with bipolar I depression. The purpose of this study is to evaluate the safety and efficacy of an investigational drug for bipolar I depression in children and adolescents. The Balance Study will enroll about 380 children and adolescents with bipolar I depression at participating study centers throughout North America. After completing 8 visits in the Balance Study, you may be able to participate in an open-label study.

Who can take part 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
• Have a diagnosis of bipolar I disorder
• Are currently experiencing an episode of depression:
– Symptoms of depression include feeling sad, down, or depressed, not enjoying things you usually do, suicidal thoughts, difficulty falling or staying asleep, loss of energy, difficulty concentrating

There is no cost to participate in the study. Patients who take part will receive all study-related visits, tests, and investigational drug from a dedicated medical team at no cost. No health insurance is required.