NCT06221358

Pharmacogenomics of Stimulant Treatment Response

Pharmacogenomics of Stimulant Treatment Response in Children and Adolescents With Attention-Deficit/ Hyperactivity Disorder

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 6 Years – 24 Years
• Healthy volunteers: Not accepted

Summary

The "Pharmacogenomics of Stimulant Treatment Response" (PGx-STaR) study aims to identify genetic profiles related to methylphenidate treatment outcomes in children and adolescents aged 6-24 with Attention deficit/hyperactivity disorder (ADHD).

Detailed description

Background: ADHD is a common neurodevelopmental disorder affecting children and adolescents, with psychostimulants, specifically slow-release methylphenidate (e.g., Biphentin®, Concerta®), being a first-line treatment option. However, the response to medications varies significantly among individuals, with some experiencing limited benefits or intolerable side effects. Unlike other areas of psychiatry, ADHD pharmacotherapy lacks genetic markers to guide treatment decisions, resulting in delayed symptom relief and diminished quality of life for patients. Objectives: 1. Identifying genomic profiles associated with psychostimulant treatment response and tolerability in children and adolescents with ADHD. 2. Establishing a research platform for the discovery of new genetic and non-genetic markers of drug treatment outcomes relevant to mental health care in children.

Conditions

• Attention-Deficit/ Hyperactivity Disorder (ADHD)

Timeline

• Start date: 2024-04-01
• Primary completion: 2028-08-31
• Completion: 2028-12-31
• First posted: 2024-01-24
• Last updated: 2025-12-05

Locations

1 site across 1 country: Canada