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NCT Number: NCT06221358

Pharmacogenomics of Stimulant Treatment Response

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).

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Key information

Conditions

Attention-Deficit/ Hyperactivity Disorder (ADHD) Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–24 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Calgary

Calgary, Alberta, Canada

Location status: Recruiting

Location contact

Chad Bousman, MPH, PhD

PRINCIPAL_INVESTIGATOR

Kara Murias, MD, PhD

SUB_INVESTIGATOR

Madison Heintz, MSW

CONTACT

[email protected]

5875739747

Paul Arnold, MD, PhD

SUB_INVESTIGATOR

About this study

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:

  • Identifying genomic profiles associated with psychostimulant treatment response and tolerability in children and adolescents with ADHD.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

  1. Change in ADHD symptom severity

    Time frame: 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.

  2. Side effect frequency and severity

    Time frame: 1, 2, 3, and 4 weeks post-baseline

    CADDRA ADHD Medication and Side Effect Form

Secondary outcomes

  1. Methylphenidate/ritalinic acid exposure

    Time frame: 4 weeks post-baseline

    Methylphenidate and ritalinic acid trough plasma levels

  2. Change in working memory

    Time frame: 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.

  3. Change in attention

    Time frame: 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.

  4. Change in inhibitory control

    Time frame: 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.

  5. Change in impulse control

    Time frame: 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.

  6. Change in functioning

    Time frame: Baseline and 4 weeks post-baseline

    Columbia Impairment Scale. Score range 0-52, with higher scores indicative of worse outcome.

  7. Change in child quality of life

    Time frame: 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.

  8. Change in carer quality of life

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Madison Heintz, MSW

CONTACT

[email protected]

5875739747

Weng-Sam Siu, MSPT, MSc

CONTACT

[email protected]

5875739747

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

Pharmacogenomics of Stimulant Treatment Response in Children and Adolescents With Attention-Deficit/ Hyperactivity Disorder

Acronym: PGx-STaR

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jan 24, 2024
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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