Pharmacogenetic Supported Prescribing in Kids (PGx-SParK)

University of Calgary

Status: Enrolling

Conditions: Mental Health Impairment

Treatments: Diagnostic Test: Pharmacogenetic Testing

Study type: Interventional

Funder types: Other

Identifiers

NCT04797364

REB20-0900

Details and patient eligibility

About

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

Full 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.

Enrollment: 6,000 estimated patients

Sex: All

Ages: 6 to 24 years old

Volunteers: No 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, 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6,000 participants in 1 patient group

Pharmacogenetic Testing

Experimental group

Description:

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

Treatment:

Diagnostic Test: Pharmacogenetic Testing