Attention-Deficit/ Hyperactivity Disorder (ADHD)PGx-STaRNCT06221358
Pharmacogenomics of Stimulant Treatment Response
An observational study of Attention-Deficit/ Hyperactivity Disorder (ADHD), run by University of Calgary at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 24 years
- Conditions the study is for
- Attention-Deficit/ Hyperactivity Disorder (ADHD)
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2024to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescent with primary diagnosis of ADHD (all types), aged 6-24 years.
Who may be able to join
- Patients will be eligible for participation if all the following are true.
- Aged 6 - 24 years.
- Located in Canada.
- Primary diagnosis of ADHD (all types).
- Starting Methylphenidate (excluding immediate release forms) treatment.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Calgary
Calgary, Alberta
Madison Heintz, MSW, 5875739747, psychpgxlab@ucalgary.ca
Chad Bousman, MPH, PhD
About this study
Official title: Pharmacogenomics of Stimulant Treatment Response in Children and Adolescents With Attention-Deficit/ Hyperactivity Disorder
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).
Read the 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:
- 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.
- Keywords
- Children, Adolescents, ADHD, Pharmacogenetics, Neurology, Psychostimulants, Methylphenidate
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 1, 2, 3, and 4 weeks post-baseline
Side effect frequency and severity
CADDRA ADHD Medication and Side Effect Form
Measured: 1, 2, 3, and 4 weeks post-baseline
Secondary outcomes (8)
Methylphenidate/ritalinic acid exposure
Methylphenidate and ritalinic acid trough plasma levels
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 4 weeks post-baseline
Change in functioning
Columbia Impairment Scale. Score range 0-52, with higher scores indicative of worse outcome.
Measured: 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.
Measured: 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.
Measured: Baseline and 4 weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Apr 2024
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-Deficit/ Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chad Bousman, University of Calgary
- Investigators
- Chad Bousman, MPH, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221358
- Sponsor's protocol ID
- REB23-0366
- Acronym
- PGx-STaR
- Status last verified
- Oct 2026
- First submitted
- 2 Jan 2024
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomics of Stimulant Treatment Response in Children and Adolescents With Attention-Deficit/ Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT06221358
- Acronym / sponsor ID
- PGx-STaR / REB23-0366
- Keywords
- Children, Adolescents, ADHD, Pharmacogenetics, Neurology, Psychostimulants, Methylphenidate
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescent with primary diagnosis of ADHD (all types), aged 6-24 years.
Key inclusion criteria (5 listed)
- Patients will be eligible for participation if all the following are true.
- Aged 6 - 24 years.
- Located in Canada.
- Primary diagnosis of ADHD (all types).
- Starting Methylphenidate (excluding immediate release forms) treatment.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Side effect frequency and severity
Time frame: 1, 2, 3, and 4 weeks post-baseline
CADDRA ADHD Medication and Side Effect Form
8 secondary outcomes
Methylphenidate/ritalinic acid exposure
Time frame: 4 weeks post-baseline
Change in working memory
Time frame: Baseline and 4 weeks post-baseline
Change in attention
Time frame: Baseline and 4 weeks post-baseline
Change in inhibitory control
Time frame: Baseline and 4 weeks post-baseline
Change in impulse control
Time frame: Baseline and 4 weeks post-baseline
Change in functioning
Time frame: Baseline and 4 weeks post-baseline
Change in child quality of life
Time frame: Baseline and 4 weeks post-baseline
Change in carer quality of life
Time frame: Baseline and 4 weeks post-baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Yes. 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).
Related trials for Attention-Deficit/ Hyperactivity Disorder (ADHD)
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chad Bousman, MPH, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention-Deficit/ Hyperactivity Disorder (ADHD), run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weng-Sam Siu, MSPT, MSc (5875739747, sam.siu@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ADHD symptom severity (time frame: Baseline and 1, 2, 3, and 4 weeks post-baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.