Research Study for Children and Teens With ADHD and Dyslexia
What is the purpose of this study?
Cincinnati Children’s is conducting a research study to evaluate how safe and effective atomoxetine (an approved medication for treating attention deficit hyperactivity disorder –ADHD) is, in treating children and teens with ADHD and dyslexia.
Who will be included in this study?
Children and teens 10 to 16 years old who have ADHD and dyslexia may be eligible to participate.
What is involved?
The study lasts for up to 32 weeks and includes 11 study visits. A detailed list of procedures will be provided to those interested in knowing more about this study. Here are some of the procedures:
- Physical exam
- Blood draws
- Urine samples
- Electrocardiogram (ECG), a type of test that looks at the signals of the heart
- ADHD symptom assessment
- Teacher feedback about how well the study medication is working for your child
- The study medication atomoxetine will be given to some of the participants, depending upon your child’s group
What are the benefits?
Although atomoxetine is being tested as a possible treatment for a condition that your child may have, your child may not receive any medical benefit. The information learned from this research study may benefit other patients with ADHD and dyslexia in the future.
Will I get all the facts about the study?
Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. The form covers all of the procedures, the risks, the benefits, the pay, who to contact with questions or concerns and more. 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 risks and discomforts of this study?
Very common side effects reported by children and teenagers who have taken the study medication atomoxetine include headache, decreased appetite, stomach pain, nausea and vomiting. Other common side effects include sleepiness, being tired or irritable, dizziness, loss of appetite, weight loss, stomach pain, sinus drainage, trouble sleeping and rash. As the study includes blood draws, your child may experience pain, bruising or temporary discomfort at the site of the blood collection. A detailed list of possible side effects will be provided to those parents or guardians interested in knowing more about this study.
What is the pay?
Families will receive up to $485 for time and travel.
Who should I contact for more information?
Anna Bartels, Research Assistant
513-803-0068
Behavioral Medicine and Clinical Psychology
Cincinnati Children’s Hospital Medical Center, MLC 10006
3333 Burnet Ave.
Cincinnati, OH 45229-3039
Principal Investigator:
Jeffery Epstein, PhD
Behavioral Medicine and Clinical Psychology
Cincinnati Children’s Hospital Medical Center
