RECRUITING

Carboxylesterase 1 Genetic Variation and Methylphenidate in ADHD

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Conditions

ADHDAttention Deficit Hyperactivity DisorderPK StudyPD StudyPharmacokineticsPharmacodynamicsMethylphenidateMPH

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Carboxylesterase 1 Genetic Variation and Methylphenidate in ADHD

Quick Facts

Study Start:2018-03-04
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03781752

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Participants that do not have ADHD as a primary diagnosis
  2. * 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
  3. * Participants that are smokers or, are pregnant

Contacts and Locations

Study Contact

Beth Krone, PhD
CONTACT
212-241-8012
beth.krone@mssm.edu
John Markowitz, PharmD
CONTACT

Principal Investigator

Jeffrey Newcorn, MD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Mark Stein, PhD
PRINCIPAL_INVESTIGATOR
University of Washington
Tanya Froehlich, MD
PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

University of Florida
Gainesville, Florida, 32610
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Jeffrey Newcorn, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai
  • Mark Stein, PhD, PRINCIPAL_INVESTIGATOR, University of Washington
  • Tanya Froehlich, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-03-04
Study Completion Date2025-08

Study Record Updates

Study Start Date2018-03-04
Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • ADHD
  • Attention Deficit Hyperactivity Disorder