Who can take part in the Engage-11 Study?

Your child or the child in your care may be eligible to join the Engage 11 study if he or she:

• is 12 to 17 years old
• has been diagnosed with MDD (major depressive disorder) or has been having feelings of depression

What is the Study drug?

The study drug for the Engage-11 study drug is an investigational drug that will be consumed in the form of a capsule. It should be taken orally once daily, at the same time each day.

What will the Study Involve?

This study will include about 660 patients with MDD at approximately 80 participating sites.

The study will last for up to 10 weeks with 9 visits including a screening period and 9 weeks of treatment with the investigational study drug or placebo. If qualified, participants may receive modest compensation for your time and travel.

The study procedures include the collection of the participant’s medical and psychiatric history, physical exam, blood and urine tests, ECG and some other medical tests.

Will I be compensated for time and travel?

Volunteers who take part in the study may be compensated per study site visit for time and travel. You can discuss this with the research team.

What else do I need to consider?

The research team will be able to explain more about what the Engage-11 Study will involve and it is up to you 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.