Increased Plasma Concentrations of 6-oxo-Methylphenidate in CES1 G134E Carriers Following a Single Oral Dose of Methylphenidate.
Qingchen Zhang, Philip W Melchert, Ahmed Awad...
https://pubmed.ncbi.nlm.nih.gov/41567292Actively Recruiting
Phase 4
Age: 6Years - 17Years
All Genders
ID03781752
Carboxylesterase 1 Genetic Variation and Methylphenidate in ADHD
Led by Icahn School of Medicine at Mount Sinai · Updated on 2024-08-09
500
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the relationship between genetic differences in the enzyme Carboxylesterase 1 (CES1) and how the drug methylphenidate (MPH) works for children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD). MPH is a commonly prescribed stimulant for ADHD, but many patients experience different effects and side effects that are not well understood. This study aims to identify how specific CES1 gene variants affect the way MPH is processed in the body and its therapeutic outcomes. Participants in this study will receive a single dose of methylphenidate, with the exact dose determined by the study team. The focus is on understanding how CES1 genetic variants influence the metabolism of MPH by measuring drug concentrations in the blood over an 8-hour period after dosing. This includes assessing the highest plasma concentration and other pharmacokinetic measures. During the study, participants will undergo blood sampling to monitor methylphenidate levels and related pharmacokinetic outcomes. Researchers will evaluate the maximum plasma concentration of MPH, as well as the time to reach this concentration and the overall drug exposure over time. The study involves youth aged 6 to 17 years diagnosed primarily with ADHD and includes safety monitoring to ensure participant well-being throughout the trial period, which started in 2018 and is expected to finish in 2025.
CONDITIONS
Brief Title
Carboxylesterase 1 Genetic Variation and Methylphenidate in ADHD
Who Can Participate
Age: 6Years - 17Years
All Genders
Eligibility Criteria
You may qualify if you...
- Youth ages 6-17 years with ADHD as a primary diagnosis
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 8 hours
Participants receive a single dose of methylphenidate to study its metabolism and therapeutic response in ADHD.
1 treatment visit with pharmacokinetic assessments over 8 hours
Trial Site Locations
Total: 4 locations
1
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
2
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
3
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Completed
4
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Terminated
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Research Team
B
Beth Krone, PhD
J
John Markowitz, PharmD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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