Recruiting

Methylphenidate with Genetic Variation

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT03781752

Conditions

ADHD

Attention Deficit Hyperactivity Disorder

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Methylphenidate

Study Details

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 and the PK and PD of MPH.

Conditions

ADHD

Attention Deficit Hyperactivity Disorder

Study ID

NCT03781752

Start date

Mar 4, 2018

Status verified date

Aug, 2024

Completion date

Aug, 2025

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Methylphenidate

Youth with ADHD

Interventions

Methylphenidate

study to determine dose

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Beth Krone, PhD

212-241-8012beth.krone@mssm.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Ben Burkley

352-273-5283burkley@cop.ufl.edu

Principal Investigator:

John Markowitz, PharmD

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Beth Krone

212-241-8012beth.krone@mssm.edu

Jeffrey Newcorn, MD

212-659-8775jeffrey.newcorn@mssm.edu

Principal Investigator:

Jeffrey Newcorn, MD

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Aug 9, 2024

Last verified

Aug, 2024

Keywords

  • PK Study
  • PD Study
  • Pharmacokinetics
  • Pharmacodynamics
  • Methylphenidate
  • MPH

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2024-08-09.