Carboxylesterase 1 Genetic Variation and Methylphenidate in ADHD

• Status: Recruiting
• Trial end date: 2023-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Youth ages 6-26 years with ADHD as a primary diagnosis

• Participants that are healthy, nonsmokers and are not pregnant

• Participants are receiving or about to receive methylphenidate for treatment of ADHD from their care providers

• Newly enrolled youth who have the targeted CES1 variants

• Youth with banked samples who have the targeted CES1 variants and had agreed to be re-contacted for future studies

• Age/sex matched controls with ADHD but without the targeted variants will be eligible for inclusion in the 8 hour PK study

Exclusion Criteria:

• Participants that do not have ADHD as a primary diagnosis

• Participants that do not want, require, or are not healthy enough for medication treatment with MPH for ADHD per the clinical judgment of the treating and study clinicians

• Participants that are smokers or, are pregnant