Image

Pharmacogenomics of Stimulant Treatment Response

Recruiting
6 - 24 years of age
Both
Phase N/A

Powered by AI

Overview

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).

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.

Eligibility

Inclusion Criteria:

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.

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.

Study details

Attention-Deficit/ Hyperactivity Disorder (ADHD)

NCT06221358

University of Calgary

31 March 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.