PGx-SParK: Pharmacogenetic Supported Prescribing in Kids

Sponsor

University of Calgary (Other)

Overall Status

Recruiting

CT.gov ID

NCT04797364

Collaborator

(none)

6,000

Enrollment

Location

Arm

53.4

Anticipated Duration (Months)

112.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Implementation of pharmacogenetic testing for children and adolescents aged 7-17 who are starting or changing psychiatric medication.

Condition or Disease	Intervention/Treatment	Phase
Mental Health Impairment	Diagnostic Test: Pharmacogenetic Testing	N/A

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:

Implement Canada's first pharmacogenetics testing service to improve drug treatment outcomes in children receiving mental health care.
Collect performance, outcome, and economic indicators related to the pharmacogenetics testing service.
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 Design

Study Type:

Interventional

Anticipated Enrollment :

6000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Pharmacogenetic Supported Prescribing in Kids

Actual Study Start Date :

Jan 18, 2021

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pharmacogenetic Testing Pharmacogenetic testing panel (CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A5, NUDT15, SLCO1B1, TPMT, VKORC1)	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

Arm

Intervention/Treatment

Experimental: Pharmacogenetic Testing

Pharmacogenetic testing panel (CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A5, NUDT15, SLCO1B1, TPMT, VKORC1)

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

Outcome Measures

Primary Outcome Measures

Adverse drug reactions [6-months]
Relative change in adverse drug reaction frequency
Symptom severity [6-months]
Relative change in symptom severity

Secondary Outcome Measures

Healthcare utilization [6-months]
Relative change in healthcare utilization

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 requests pharmacogenetic testing