Genetic factors affecting methylphenidate treatment in ADHD
Carboxylesterase 1 Genetic Variation and Methylphenidate in ADHD
PHASE4 · Icahn School of Medicine at Mount Sinai · NCT03781752
This study is testing how genetic differences in kids with ADHD affect how well they respond to the medication methylphenidate and whether they experience side effects from it.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai (other) |
| Locations | 4 sites (Gainesville, Florida and 3 other locations) |
| Trial ID | NCT03781752 on ClinicalTrials.gov |
What this trial studies
This study investigates how genetic variations in the CES1 gene influence the effectiveness and side effects of methylphenidate (MPH) in treating Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents. By analyzing the pharmacokinetics (PK) and pharmacodynamics (PD) of MPH, the research aims to identify why some patients respond poorly to the medication while others experience significant adverse effects. The study will involve youth aged 6-17 years diagnosed with ADHD, who will receive a single dose of MPH to assess their response based on their genetic makeup. This could lead to more personalized treatment approaches for ADHD.
Who should consider this trial
Good fit: Ideal candidates for this study are youth aged 6-17 years with a primary diagnosis of ADHD.
Not a fit: Patients who do not have ADHD as a primary diagnosis or those who are pregnant or smokers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and safer treatment options for children with ADHD by tailoring medication based on genetic profiles.
How similar studies have performed: Other studies have explored genetic influences on ADHD treatments, but this specific approach focusing on CES1 genetic variation and MPH is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Youth ages 6-17 years with ADHD as a primary diagnosis Exclusion Criteria: * Participants that do not have ADHD as a primary diagnosis * Participants that do not want, require, or are not healthy enough for a single dose trial of MPH for ADHD per the clinical judgment of the treating and study clinicians * Participants that are smokers or, are pregnant
Where this trial is running
Gainesville, Florida and 3 other locations
- University of Florida — Gainesville, Florida, United States (RECRUITING)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (COMPLETED)
- Seattle Children's Hospital — Seattle, Washington, United States (TERMINATED)
Study contacts
- Principal investigator: Jeffrey Newcorn, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Beth Krone, PhD
- Email: beth.krone@mssm.edu
- Phone: 212-241-8012
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: ADHD, Attention Deficit Hyperactivity Disorder, PK Study, PD Study, Pharmacokinetics, Pharmacodynamics, Methylphenidate, MPH