Pharmacogenomics of Stimulant Treatment Response
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-24
SponsorUniversity of Calgary
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Children and adolescent with primary diagnosis of ADHD (all types), aged 6-24 years.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 1, 2, 3, and 4 weeks post-baseline2
Side effect frequency and severity
CADDRA ADHD Medication and Side Effect Form
Time frame
1, 2, 3, and 4 weeks post-baselineSecondary outcomes
1
Methylphenidate/ritalinic acid exposure
Methylphenidate and ritalinic acid trough plasma levels
Time frame
4 weeks post-baseline2
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-baseline3
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-baseline4
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.
Time frame
Baseline and 4 weeks post-baselineSponsors and contacts
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Source ClinicalTrials.gov