Pharmacogenomics of Stimulant Treatment Response
PGx-STaR
1 other identifier
observational
400
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2024
CompletedFirst Posted
Study publicly available on registry
January 24, 2024
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
December 5, 2025
November 1, 2025
4.4 years
January 2, 2024
November 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in ADHD symptom severity
Strengths and Weaknesses of Attention-Deficit/Hyperactivity Symptoms and Normal Behavior Scale (SWAN) Rating Scale for ADHD. Score range = -90 to +90, with higher scores indicative of worse outcome.
Baseline and 1, 2, 3, and 4 weeks post-baseline
Side effect frequency and severity
CADDRA ADHD Medication and Side Effect Form
1, 2, 3, and 4 weeks post-baseline
Secondary Outcomes (8)
Methylphenidate/ritalinic acid exposure
4 weeks post-baseline
Change in working memory
Baseline and 4 weeks post-baseline
Change in attention
Baseline and 4 weeks post-baseline
Change in inhibitory control
Baseline and 4 weeks post-baseline
Change in impulse control
Baseline and 4 weeks post-baseline
- +3 more secondary outcomes
Eligibility Criteria
Children and adolescent with primary diagnosis of ADHD (all types), aged 6-24 years.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Calgary
Calgary, Alberta, Canada
Biospecimen
Participants will donate a 2 mL (teaspoon) sample of saliva and 0.07 mL (1/64th of a teaspoon) of blood via a needle-free collection device.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chad Bousman, MPH, PhD
University of Calgary
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 2, 2024
First Posted
January 24, 2024
Study Start
April 1, 2024
Primary Completion (Estimated)
August 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
December 5, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Access Criteria
- 1. The requestor is affiliated with an academic institution as an independent investigator or trainee of an independent investigator; 2. The proposed research question(s) and hypothesis(es) are specific, measurable, and achievable; 3. The proposed research project will be governed/overseen by a local legal/regulatory body; 4. The proposed research project poses no risk of invasion of privacy or breaches of confidentiality for trial participants; 5. A member of the proposed research team has sufficient statistical skills to carry out the proposed analytic plan; 6. The requestor has sufficient financial and/or human resources to see the proposed research project to completion; 7. The proposed research question(s) and hypothesis(es) do not conflict with active or planned studies of the Co-Principal Investigators.
Anonymized, individual participant PGx-STaR data will be shared using a controlled-access model. Under this model, the data will be released to a researcher if access criteria are met. All requests for data sharing should be made to the Co-Principal Investigators who will be responsible for reviewing and granting requests. Requestors should provide a research proposal for review. In the event that a data sharing request is declined, reasons will be provided to the requestor. If the data sharing request is granted, a data-sharing agreement will be initiated by the Co-Principal Investigators alongside the University of Calgary (lead institution). This agreement will include information on the individual data to be shared; if other documents will be available (e.g., statistical codes, data dictionary), when the data will be available and for how long, and how data access will be provided (e.g., file transfer).