Status:
RECRUITING
Pharmacogenomics of Stimulant Treatment Response
Lead Sponsor:
University of Calgary
Conditions:
Attention-Deficit/ Hyperactivity Disorder (ADHD)
Eligibility:
All Genders
6-24 years
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 Atten...
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 fir...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06221358
Start Date
April 1 2024
End Date
December 31 2028
Last Update
December 5 2025
Active Locations (1)
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1
University of Calgary
Calgary, Alberta, Canada