Recruiting

Pharmacogenomics

Sponsor:

University of Calgary

Code:

NCT06221358

Conditions

Attention-Deficit/ Hyperactivity Disorder (ADHD)

Eligibility Criteria

Sex: All

Age: 6 - 24

Healthy Volunteers: Not accepted

Study Details

Brief 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).

Conditions

Attention-Deficit/ Hyperactivity Disorder (ADHD)

Study ID

NCT06221358

Start date

Apr 1, 2024

Status verified date

Nov, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 24

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Change in ADHD symptom severity [ Time Frame: Baseline and 1, 2, 3, and 4 weeks post-baseline ]
  • Side effect frequency and severity [ Time Frame: 1, 2, 3, and 4 weeks post-baseline ]

Central Contacts and Locations

Central contacts

Weng-Sam Siu, MSPT, MSc

5875739747sam.siu@ucalgary.ca

Madison Heintz, MSW

5875739747psychpgxlab@ucalgary.ca

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada

Contacts

Madison Heintz, MSW

5875739747psychpgxlab@ucalgary.ca

Principal Investigator:

Chad Bousman, MPH, PhD

More Information

Sponsor

University of Calgary

Last update posted

Dec 5, 2025

Last verified

Nov, 2025

Keywords

  • Children
  • Adolescents
  • ADHD
  • Pharmacogenetics
  • Neurology
  • Psychostimulants
  • Methylphenidate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2025-12-05.