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: 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.
Study Type
OBSERVATIONAL
Enrollment
400
University of Calgary
Calgary, Alberta, Canada
RECRUITINGChange 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.
Time frame: Baseline and 1, 2, 3, and 4 weeks post-baseline
Side effect frequency and severity
CADDRA ADHD Medication and Side Effect Form
Time frame: 1, 2, 3, and 4 weeks post-baseline
Methylphenidate/ritalinic acid exposure
Methylphenidate and ritalinic acid trough plasma levels
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: Baseline and 4 weeks post-baseline
Change in functioning
Columbia Impairment Scale. Score range 0-52, with higher scores indicative of worse outcome.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 4 weeks post-baseline