NCT04797364

Pharmacogenetic Supported Prescribing in Kids

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6,000 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 6 Years – 24 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mental Health Impairment

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Pharmacogenetic Testing	Participants will donate a 2ml (teaspoon) sample of saliva. DNA extracted from the saliva sample will be used for genotyping. Genotyping results will be translated into an interpretative clinical report using evidence-based software (Sequence2Script) developed by our group and delivered to the treating physician for use in their clinical decision-making. The report will contain genotyping results, predicted phenotype, and evidence-based drug selection and dosing recommendations relevant to the child's current and future care

Timeline

• Start date: 2021-01-18
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2021-03-15
• Last updated: 2024-05-09

Locations

1 site across 1 country: Canada