Clinical Trials / Research Studies

Clinical Trials / Research Studies

What will happen in the study?

The study involves up to 9 visits at the study center over 2 months. Here are some of the things that will happen in this study.

To find out the best way of treating children and teens with bipolar disorder, we need to compare different treatments. People are placed into groups, and each group is given a different study treatment. Each participant is put into a group by chance (this is called randomization). Participants in this study have a 1 in 2 chance of being randomly assigned (like flipping a coin) to receive the placebo or study drug.

If your child is taking certain medications not allowed in this study, you will be asked to discontinue those little by little during the screening period, under the supervision of the study doctor. Your child 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.

Your child will:

• Fast overnight for at least 8 hours before the study center visits when blood or urine 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.
• 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, as the parent or guardian, will be given a supply of study drug for your child to take once each evening, under your supervision. The study team will advise you and your child about how best to take the study drug.

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.