Carboxylesterase 1 Genetic Variation and Methylphenidate in ADHD

NCT03781752 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: GCO 17-02811R01HD093612-01A1
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 4

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

Keywords

PK Study; PD Study; Pharmacokinetics; Pharmacodynamics; Methylphenidate; MPH

Outcome Measures

Primary Outcomes (1)

• Maximum methylphenidate plasma concentration (Cmax),

  The maximum plasma concentration achieved after dosing.

  up to 8 Hours

Secondary Outcomes (3)

• Time to maximum concentration (Tmax)

  up 8 hours

• Area under the plasma concentration curve (AUClast)

  up to 8 hours

• Area under the plasma concentration curve (AUCinf)

  up to 8 hours

Study Arms (1)

Methylphenidate

EXPERIMENTAL

Youth with ADHD

Drug: Methylphenidate

Interventions

Methylphenidate DRUG

study to determine dose

Also known as: d,l-methylphenidate, MPH

Methylphenidate

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- Youth ages 6-17 years with ADHD as a primary diagnosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of Florida: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• Seattle Children's Hospital: collaborator

Study Sites (4)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

COMPLETED

Seattle Children's Hospital

Seattle, Washington, 98105, United States

TERMINATED

Related Publications (1)

• Zhang Q, Melchert PW, Awad A, McCurdy CR, Krone B, Newcorn J, Froehlich TE, Stein MA, Raeuscher J, Zhu HJ, Markowitz JS. Increased Plasma Concentrations of 6-oxo-Methylphenidate in CES1 G134E Carriers Following a Single Oral Dose of Methylphenidate. Med Chem Res. 2025 Nov;34(11):2318-2327. doi: 10.1007/s00044-025-03477-3. Epub 2025 Oct 2.

  PMID: 41567292 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate; 5,10-dihydro-5-methylphenazine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jeffrey Newcorn, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Mark Stein, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Tanya Froehlich, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beth Krone, PhD

CONTACT

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

John Markowitz, PharmD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study team is performing a pharmacokinetic (PK) study using a single dose of methylphenidate (MPH) for children with ADHD diagnoses.

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 20, 2018
• Study Start: March 4, 2018
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)