Status:
RECRUITING
Carboxylesterase 1 Genetic Variation and Methylphenidate in ADHD
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Florida
Conditions:
ADHD
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
Brief Summary
The study team will determine the association between d,l-methylphenidate (MPH) therapeutic outcomes in ADHD patients and genetic variants of CES1 and reveal key associations between CES1 genotypes an...
Detailed Description
Psychostimulants are the first-line pharmacotherapy for Attention deficit-hyperactivity disorder (ADHD), and MPH accounts for approximately 50% of all stimulant usage. There has been an \~10-fold incr...
Eligibility Criteria
Inclusion
- \- Youth ages 6-17 years with ADHD as a primary diagnosis
Exclusion
- 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
Key Trial Info
Start Date :
March 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03781752
Start Date
March 4 2018
End Date
August 1 2025
Last Update
August 9 2024
Active Locations (4)
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1
University of Florida
Gainesville, Florida, United States, 32610
2
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
3
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
4
Seattle Children's Hospital
Seattle, Washington, United States, 98105