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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).
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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Methylphenidate/ritalinic acid exposure | Methylphenidate and ritalinic acid trough plasma levels | 4 weeks post-baseline |
| Change in working memory | Sorting Working Memory Test (7 minutes; administered orally and online with research team member). An assessment of working memory. A participant is asked to recall and sequence different stimuli that are presented visually and via audio. Higher scores indicate better outcome. |
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Inclusion Criteria:
Patients will be eligible for participation if all the following are true.
Exclusion Criteria:
Patients will be excluded from participation if any of the following are true.
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Children and adolescent with primary diagnosis of ADHD (all types), aged 6-24 years.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weng-Sam Siu, MSPT, MSc | Contact | 5875739747 | sam.siu@ucalgary.ca | |
| Madison Heintz, MSW | Contact | 5875739747 | psychpgxlab@ucalgary.ca |
| Name | Affiliation | Role |
|---|---|---|
| Chad Bousman, MPH, PhD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Recruiting | Calgary | Alberta | Canada |
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).
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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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.
| Baseline and 4 weeks post-baseline |
| Change in attention | Dimension Change Card Sort Test (8 minutes; administered online). An assessment of cognitive flexibility and attention. A participant is asked to match a series of picture pairs to a target picture. Higher scores indicate better outcome. | Baseline and 4 weeks post-baseline |
| Change in inhibitory control | Flanker Inhibitory Control and Attention Test (7 minutes; administered online). An assessment of inhibitory control and attention. A participant is asked to focus on a particular stimulus while inhibiting attention to the stimuli flanking it. Higher scores indicate better outcome. | Baseline and 4 weeks post-baseline |
| Change in impulse control | Stop Signal Task (10 minutes; administered online). An assessment of impulse control. A participant is presented with a target stimulus and are asked to respond to the stimulus as fast as possible. Higher score indicate better outcome. | Baseline and 4 weeks post-baseline |
| Change in functioning | Columbia Impairment Scale. Score range 0-52, with higher scores indicative of worse outcome. | Baseline and 4 weeks post-baseline |
| Change in child quality of life | Pediatric Quality of Life Inventory (PedsQoL). Items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better quality of life. | Baseline and 4 weeks post-baseline |
| Change in carer quality of life | Care-related Quality of Life instrument (Carer QoL-7D). Utility tariffs for the CarerQol have been developed to calculate a CarerQol-7D utility score from the responses on the seven dimensions, ranging between 0 ('worst imaginable caregiving situation') and 100 ('best imaginable caregiving situation'). Higher utility scores thus reflect better care-related quality of life. | Baseline and 4 weeks post-baseline |