Pharmacogenetic Supported Prescribing in Kids

Study Overview
=================
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: 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.

Official Title
-----------------
Pharmacogenetic Supported Prescribing in Kids

Conditions
-----------------
Mental Health Impairment

Intervention / Treatment
-----------------
* Diagnostic Test: Pharmacogenetic Testing


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 24 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacogenetic Testing<br>Pharmacogenetic testing panel (CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A5, NUDT15, SLCO1B1, TPMT, VKORC1) | Diagnostic Test: Pharmacogenetic Testing<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse drug reactions | Relative change in adverse drug reaction frequency | 6-months | 
| Symptom severity | Relative change in symptom severity | 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare utilization | Relative change in healthcare utilization | 6-months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Child, Adolescent, Mental Health, Psychiatry, Pharmacogenetics, Depression, Anxiety, OCD, Psychosis, Bipolar Disorder