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 — DRUG
    study 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: Methylphenidate
    Youth with ADHD

Primary Outcome Measure

Maximum methylphenidate plasma concentration (Cmax), [ Time Frame: up to 8 Hours ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610
Ben Burkley
352-273-5283
John Markowitz, PharmD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Beth Krone
212-241-8012
Jeffrey Newcorn, MD
212-659-8775
Jeffrey Newcorn, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Seattle Children's HospitalSeattleWashington98105-

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