Pharmacogenomics of Stimulant Treatment Response

NCT ID: NCT06221358

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2028-12-31

Brief Summary

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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

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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.

Conditions

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Attention-Deficit/ Hyperactivity Disorder (ADHD)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Chad Bousman

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chad Bousman, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

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University of Calgary

Calgary, Alberta, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Weng-Sam Siu, MSPT, MSc

Role: CONTACT

5875739747

Madison Heintz, MSW

Role: CONTACT

5875739747

Facility Contacts

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Madison Heintz, MSW

Role: primary

5875739747

Other Identifiers

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REB23-0366

Identifier Type: -

Identifier Source: org_study_id

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