Clinical Trials / Research Studies
Clinical Trials / Research Studies

ADHD Study for Children 4 to 5 Years Old

Why are we doing this research?

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.

Who can participate?

Children 4 to 5 years old who have been diagnosed with ADHD may be eligible to participate.

Conditions

  • ADD / ADHD

What will happen in the study?

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:

  • Be asked some questions and complete some questionnaires.
  • Stop taking some of their prescription and nonprescription medicines if needed at least 3 days before the first study visit.
  • Be assigned by chance (by a computer) to either take the study drug or placebo.
  • Take the study medicine as instructed.
  • Tell the study staff about any treatment prescribed to your child during this study.
  • Not start any new behavioral therapies or other ADHD treatments while taking part in this study.
  • Complete paper diaries and questionnaires as instructed.

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.

What are the good things that can happen from this research?

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.

What are the bad things that can happen from this research?

We will discuss possible risks or discomforts with you prior to the start of the study.

Will you/your child be paid to be in this research study?

Compensation will be available for study time and travel.

Contact

Contact Us.

Bhavana Ramachandran
ramachba@ucmail.uc.edu
513-558-4413
University of Cincinnati
3333 Burnet Ave.
Cincinnati, OH 45229-3039

Study Doctor

Contact Us.

Melissa P. Delbello, MD, MS
Psychiatry & Behavioral Neuroscience
University of Cincinnati College of Medicine