Pharmacogenomics of Stimulant Treatment Response
- Conditions
- Attention-Deficit/ Hyperactivity Disorder (ADHD)
- Registration Number
- NCT06221358
- Lead Sponsor
- University of Calgary
- 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).
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
Patients will be eligible for participation if all the following are true.
- Aged 6 - 24 years
- Located in Alberta, Canada.
- Primary diagnosis of ADHD (all types).
- Initiating methylphenidate (excluding immediate release (IR) forms) treatment.
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Side effect frequency and severity 1, 2, 3, and 4 weeks post-baseline CADDRA ADHD Medication and Side Effect Form
Change in ADHD symptom severity Baseline and 1, 2, 3, and 4 weeks post-baseline 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.
- Secondary Outcome Measures
Name Time Method Methylphenidate/ritalinic acid exposure 4 weeks post-baseline Methylphenidate and ritalinic acid trough plasma levels
Change in impulse control Baseline and 4 weeks post-baseline 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.
Change in functioning Baseline and 4 weeks post-baseline Columbia Impairment Scale. Score range 0-52, with higher scores indicative of worse outcome.
Change in working memory Baseline and 4 weeks post-baseline 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.
Change in attention Baseline and 4 weeks post-baseline 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.
Change in inhibitory control Baseline and 4 weeks post-baseline 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.
Change in child quality of life Baseline and 4 weeks post-baseline 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.
Change in carer quality of life Baseline and 4 weeks post-baseline 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.
Trial Locations
- Locations (1)
University of Calgary
🇨🇦Calgary, Alberta, Canada