Clinical Trials / Research Studies

Clinical Trials / Research Studies

What will happen in the study?

The study involves up to 14 study visits over up to 7 months. Here are some of the things that will happen in this study.

All participants in this study will receive the study drug. The study drug will be provided as capsules for your child to swallow once daily at about the same time, with or without food.

Your child can continue to take their regular antidepressant medication during the study. If not allowed, your study doctor will let you know. They will not be allowed to take any other medications during the time they are in the study, unless these are approved by the study doctor. If they are currently taking any psychiatric medications other than their regular antidepressant medication, and the study doctor thinks it is not safe for them to stop taking these medications, your child will not be eligible for the study.

In this study, your child will:

• Fast overnight for at least 8 hours before the study center visits when blood samples will be taken, except for the screening visit.
• Have a physical exam completed by the study doctor, including vital signs, height and weight measurements.
• Be asked, with you as the parent or guardian, about all medications and supplements that they take at the start of the study and during their participation.
• Complete an electrocardiogram (ECG) with sticky pads on their chest, arms, and legs. The pads are connected by wires to a machine that checks the rhythm and activity of their heart.
• Have blood tests to check for their overall health and test for certain infections, and to understand how the study drug is working in their body.
• Submit urine tests.
• Complete a breathalyzer test by blowing into a machine to see if they have taken any alcohol.
• Complete, with you as the parent or guardian, questionnaires and interviews. to evaluate your child’s psychiatric symptoms, how they are feeling, and their general health.
• If they have a menstrual period, complete a menstrual calendar and have a pregnancy test.
• If they have menstrual periods and are sexually active, they must agree to use an acceptable method of birth control from the screening period until the end of the follow-up.
• Have additional tests if needed, based on the study doctor’s decision.

You and your child will be given a consent form that thoroughly explains all the details of the study. A member of the study staff will review the consent form with you and will be sure that all your questions are answered prior to the start of the study.