Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT06221358
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2024-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacogenomics of Stimulant Treatment Response
Sponsor:
University of Calgary
Organization:
Study Overview
Official Title:
Pharmacogenomics of Stimulant Treatment Response in Children and Adolescents With Attention-Deficit/ Hyperactivity Disorder
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PGx-STaR
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: