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Pharmacogenomics of Stimulant Treatment Response (PGx-STaR)

U

University of Calgary

Status

Enrolling

Conditions

Attention-Deficit/ Hyperactivity Disorder (ADHD)

Study type

Observational

Funder types

Other

Identifiers

NCT06221358
REB23-0366

Details and patient eligibility

About

The "Pharmacogenomics of Stimulant Treatment Response" (PGx-STaR) study aims to identify genetic profiles related to methylphenidate treatment outcomes in children and adolescents aged 6-17 with Attention deficit/hyperactivity disorder (ADHD).

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients will be eligible for participation if all the following are true.

  • Aged 6 - 17 years
  • Located in Alberta, Canada.
  • Primary diagnosis of ADHD (all types).
  • Initiating methylphenidate (excluding immediate release (IR) forms) treatment for the first time.

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.

Trial contacts and locations

1

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Central trial contact

Madison Heintz, MSW

Data sourced from clinicaltrials.gov

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