Pharmacogenetic Supported Prescribing in Kids

Not Applicable

Recruiting

• Conditions: Mental Health Impairment
• Interventions: Diagnostic Test: Pharmacogenetic Testing

• Registration Number: NCT04797364
• Lead Sponsor: University of Calgary

Brief Summary

Implementation of pharmacogenetic testing for children and adolescents aged 6-24 who are starting or changing psychiatric medication.

Detailed Description

Children with moderate to severe mental health conditions (e.g. depression, anxiety, OCD) or neurodevelopmental disorders (e.g., autism spectrum disorders, ADHD) are frequently prescribed medications as either the sole form of treatment or in combination with psychotherapy. However, up to 50% of these children will not respond or experience burdensome adverse drug reactions to these medications. Current use of mental health-related medications (e.g., antidepressants, antipsychotics) in children can be best described as a trial-and-error process that can impact the well-being of those taking the medications and their families at a considerable economic cost. However, this trial-and-error process could, in part, be avoided through the application of pharmacogenetic testing, a specific type of genetic testing that has the potential to improve drug efficacy and reduce the morbidity, mortality and cost associated with adverse drug reactions. The aim of this project is to implement and evaluate an evidence-based pharmacogenetic testing service to improve drug treatment outcomes in children receiving mental health care.

Our objectives are to:

1. Implement Canada's first pharmacogenetics testing service to improve drug treatment outcomes in children receiving mental health care.

2. Collect performance, outcome, and economic indicators related to the pharmacogenetics testing service.

3. Establish 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 Timeline

• Study Start: 2021-01-18
• Study First Submitted: 2021-03-09
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

• Medical records available
• The initiation, change, dose adjustment, or augmentation of psychiatric medication(s) is indicated
• Treating psychiatrist, family physician, or pediatrician licensed in Alberta, British Columbia, Saskatchewan, or Manitoba requests pharmacogenetic testing

Exclusion Criteria

• Medically unstable or lacking capacity to provided informed consent
• Unwillingness of child to provide saliva sample for genetic analysis
• History of liver or bone marrow (hematopoietic cell) transplant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pharmacogenetic Testing	Pharmacogenetic Testing	Pharmacogenetic testing panel (CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A5, NUDT15, SLCO1B1, TPMT, VKORC1)

Primary Outcome Measures

Name	Time	Method
Adverse drug reactions	6-months	Relative change in adverse drug reaction frequency
Symptom severity	6-months	Relative change in symptom severity

Secondary Outcome Measures

Name	Time	Method
Healthcare utilization	6-months	Relative change in healthcare utilization

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada