NCT03781752 Carboxylesterase 1 Genetic Variation and Methylphenidate in ADHD
| NCT ID | NCT03781752 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | ADHD |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2018-03-04 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 500 participants in total. It began in 2018-03-04 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Jeffrey Newcorn, MD
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT03781752 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 17 Years, studying ADHD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03781752 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03781752 currently recruiting?
Yes, NCT03781752 is actively recruiting participants. Contact the research team at beth.krone@mssm.edu for enrollment information.
Where is the NCT03781752 trial being conducted?
This trial is being conducted at Gainesville, United States, New York, United States, Cincinnati, United States, Seattle, United States.
Who is sponsoring the NCT03781752 clinical trial?
NCT03781752 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Jeffrey Newcorn, MD at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 500 participants.