Carboxylesterase 1 Genetic Variation and Methylphenidate in ADHD
Part of paid clinical trials in Gainesville, Florida.
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Study ID
- NCT03781752
- Phase
- PHASE4
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 6 Years - 17 Years
- Healthy Volunteers
- Not accepted
Interventions
- Methylphenidate — DRUGstudy to determine dose
Study Details
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 and the PK and PD of MPH.
Key Dates
- Start date
- Mar 4, 2018
- Status verified
- Aug 2024
- Primary completion
- Aug 31, 2025
- Completion
- Aug 31, 2025
Study Design
- Enrollment
- 500 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: MethylphenidateYouth with ADHD
Primary Outcome Measure
Maximum methylphenidate plasma concentration (Cmax), [ Time Frame: up to 8 Hours ]
Central Contacts
- Beth Krone, PhD212-241-8012
- John Markowitz, PharmD
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | John Markowitz, PharmD (PRINCIPAL_INVESTIGATOR) |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | Jeffrey Newcorn, MD (PRINCIPAL_INVESTIGATOR) |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | - |
| Seattle Children's Hospital | Seattle | Washington | 98105 | - |
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