What will happen in the study?

We are evaluating the study drug escitalopram as a medication treatment for anxiety.

If your child qualifies, he/she will be randomly assigned (like flipping a coin) to one of two treatment groups (dose based on genetics or standard dose) of escitalopram for 12 weeks. The study is about 14 weeks long. We will not know the dose of medication your child is taking until the end of the study.

Here are some of the things that will happen in this study:

Your child will:

• Be asked about their health, how they are feeling, any medical problems, surgeries, and any medications (with your help)
• Have a physical including blood pressure, heart rate, height and weight measurements
• Have their cheek brushed with a cotton swab to collect a sample which will be used to look at their genes
• Be asked to submit blood and urine samples
• If female, be asked to have a urine pregnancy test
• If female and sexually active, need to agree to use birth control approved by the study doctor to keep her from becoming pregnant.
• Have EKGs to listen to their heart by placing sticky pads on their skin for a few minutes
• After starting the study medication, be asked about how they are feeling and decide whether they should stay in the study on their current medicine, or leave the study so that they can take a different medicine

You, as the parent or guardian, will:

• Be asked about your child has been feeling, how well he/she gets along with others, and how well he/she talks with other people
• Be given the study medication with instructions; your child must be able to swallow the capsule, without cutting, crushing, or chewing it
• Be asked, as well as your child, if they missed any dose of the study medication

This research study will collect information about your child and his/her health at every visit. This information may be given to or seen by people who work on this study, and will be kept private. Study results will not include your child’s name or anything else that would let others know who he/she is.

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