Pharmacogenomics of Stimulant Treatment Response

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

NCT06221358•University of Calgary

View on ClinicalTrials.gov

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.

Eligibility

Age

6 - 24 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients will be eligible for participation if all the following are true.
•Aged 6 - 24 years.
•Located in Western Canada (i.e., Alberta, British Columbia, Saskatchewan, Manitoba).
•Primary diagnosis of ADHD (all types).
•Starting Methylphenidate (excluding immediate release forms) treatment.

Exclusion Criteria

•Patients will be excluded from participation if any of the following are true.
•Co-occurring psychotic, bipolar or eating disorders.
•Significant risk of suicide.
•An intellectual disability, or diagnosis of autism spectrum disorder (ASD) or tics/Tourette disorders.
•Past 12-month high-risk alcohol or substance use defined as monthly or more frequent use.
•Psychotherapy or brain stimulation-based therapy initiated within 8 weeks of referral or plans to initiate/change these types of therapies during the study
•History of liver or bone marrow (hematopoietic cell) transplant as these events can result in ambiguous genomic results.

Locations (1)

University of Calgary

Calgary, Alberta, Canada

Key Dates

Start Date

April 1, 2024

Primary Completion Date

August 31, 2028

Completion Date

December 31, 2028

Last Updated

December 5, 2025

Enrollment

400

ESTIMATED participants

Conditions

Attention-Deficit/ Hyperactivity Disorder (ADHD)

Contacts

Weng-Sam Siu, MSPT, MSc

CONTACT

5875739747 sam.siu@ucalgary.ca

Madison Heintz, MSW

CONTACT

5875739747 psychpgxlab@ucalgary.ca