Clinical trial NCT06221358: Pharmacogenomics of Stimulant Treatment Response
Official title: Pharmacogenomics of Stimulant Treatment Response in Children and Adolescents With Attention-Deficit/ Hyperactivity Disorder
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Attention-Deficit/ Hyperactivity Disorder (ADHD)
Keywords: Children
Adolescents
ADHD
Pharmacogenetics
Neurology
Psychostimulants
Methylphenidate
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescent with primary diagnosis of ADHD (all types), aged 6-24 years.

Brief 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).

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:

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 criteria: 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.

Primary outcomes:
measure: Change in ADHD symptom severity
timeFrame: Baseline and 1, 2, 3, and 4 weeks post-baseline
measure: Side effect frequency and severity
timeFrame: 1, 2, 3, and 4 weeks post-baseline
Secondary outcomes:
measure: Methylphenidate/ritalinic acid exposure
timeFrame: 4 weeks post-baseline
measure: Change in working memory
timeFrame: Baseline and 4 weeks post-baseline
measure: Change in attention
timeFrame: Baseline and 4 weeks post-baseline
measure: Change in inhibitory control
timeFrame: Baseline and 4 weeks post-baseline
measure: Change in impulse control
timeFrame: Baseline and 4 weeks post-baseline
measure: Change in functioning
timeFrame: Baseline and 4 weeks post-baseline
measure: Change in child quality of life
timeFrame: Baseline and 4 weeks post-baseline
measure: Change in carer quality of life
timeFrame: Baseline and 4 weeks post-baseline
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Chad Bousman, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: