This is a University of Cincinnati research study to learn whether the study medicine, methylphenidate hydrochloride extended-release capsules, which has delayed release and extended-release properties and is taken in the evening, is beneficial for children 4 to 5 years old with ADHD. The product is approved for the treatment of ADHD in patients 6 years and older.
Children 4 to 5 years old who have been diagnosed with ADHD may be eligible to participate.
This study is expected to last for up to 9 weeks, including 3 weeks of treatment. You will have at least 5 study visits at the study center and a follow up phone call 2 weeks after the last study center visit. Extra visits may be scheduled if the study doctor feels it is best for your child.
If your child takes part in this study, you and/or your child will:
Your child should not take medicine other than the study medicine during this study, except for those permitted by their study doctor. Also, your child may not take part in other clinical research studies during this study.
Your child may or may not benefit from taking part in this study. He/she could have an improvement in their ADHD symptoms. Overall, the information we learn from the study may help other children in the future.
We will discuss possible risks or discomforts with you prior to the start of the study.
Compensation will be available for study time and travel.
Bhavana Ramachandran
ramachba@ucmail.uc.edu
513-558-4413
University of Cincinnati
3333 Burnet Ave.
Cincinnati, OH 45229-3039
Melissa P. Delbello, MD, MS
Psychiatry & Behavioral Neuroscience
University of Cincinnati College of Medicine