Carboxylesterase 1 Genetic Variation and Methylphenidate in ADHD (CES1) Study Summary

• To participate, your child must be between the ages of 6-17 years old and show signs of ADHD.

• Appointments take place in the Schubert Research Clinic (open from 7 AM - 7 PM) at Cincinnati Children’s.

• This study typically takes 2 days to complete.

• Number and duration of visits detailed below:

• 1 hour – 1.5 hour Screening visit

• You and your child will go over the consent form with study staff.

• General questions will be asked to determine study eligibility.

• Your child will have a physical exam.

• An EKG (Electrocardiogram) will be completed. This is a test that uses sensors to assess the electrical activity of your child’s heartbeat.

• Typically, the latest appointment starts at 4:00 PM.

• You will receive a $50 payment for completion of this visit.

• 7 – 8 hour Schubert Research Clinic visit (visit completed all in the same day)

• To be eligible, your child must carry certain genes. Eligibility will be determined based on a saliva or blood sample that has been provided.

• Be physically healthy and be non-smokers and non-users of nicotine in any form or dietary supplements (excluding melatonin, which may be taken) or herbal remedies. All participants must have no history of allergy, sensitivity, or intolerability to any methylphenidate formulation.

• Your child will stop taking their ADHD stimulation medication 2 days before the visit and will stop taking their atomoxetine (Strattera®) for at least 5 days prior to participation.

• Your child will arrive at the Schubert Research Clinic (SRC) early in the morning.

• They will have their blood pressure, height and weight measured, as well as an EKG.

• A small tube will be placed in their arm, so a small amount of blood can be collected at different times throughout the day (up to 8 samples).

• An hour after the first blood draw, your child will take a dose of methylphenidate to drink as a liquid.

• Blood pressure and heart rate will be recorded right before each blood collection.

• Your child should not eat or drink anything other than water after midnight before the visit. They will receive a breakfast after the first blood sample is collected (approximately 20 minutes after arriving at the SRC).

• Another EKG will be conducted during the day.

• You will be asked several times throughout the day about whether your child is experiencing any side effects.

• You will receive a $200 payment for completion of this visit.

• Compensation

• Total payment possible = $250

• Compensated $50 for the screening visit

• Compensated $200 for the Schubert Research Clinic visit

Some specific requirements of your child:

1.Must not be pregnant or breast feeding.