Anxiety Study for Preteens and Teens 12 to 17 Years Old
Why are we doing this research?
Cincinnati Children's and University of Cincinnati College of Medicine are conducting a research study, sometimes known as a clinical trial or clinical study, to evaluate which patients respond best to a medication treatment for anxiety.
Who can participate?
Preteens and teens 12 to 17 years old with generalized, separation and/or social anxiety disorders may be eligible to participate. Common anxiety symptoms include uncontrollable worrying, restlessness, sleep difficulties, and frequent worries about loved ones.
- Anxiety Disorders
- Mental Health
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.
What are the good things that can happen from this research?
There is no guarantee that your child will benefit from participating in this study. His/her anxiety may or may not get better or may even get worse while they are in the study. However, the information learned from this study may help other children who have anxiety disorder(s) in the future.
What are the bad things that can happen from this research?
Possible risks and discomforts will be discussed with those interested in learning more about the study.
Will you/your child be paid to be in this research study?
Participants will receive payment for time and travel for each completed study visit. Study visits, tests, procedures, and medication will be provided at no cost.