Clinical trial NCT04797364: Pharmacogenetic Supported Prescribing in Kids
Official title: Pharmacogenetic Supported Prescribing in Kids
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Impairment
Keywords: Child
Adolescent
Mental Health
Psychiatry
Pharmacogenetics
Depression
Anxiety
OCD
Psychosis
Bipolar Disorder
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 6000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Adverse drug reactions
timeFrame: 6-months
measure: Symptom severity
timeFrame: 6-months
Secondary outcomes:
measure: Healthcare utilization
timeFrame: 6-months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Chad Bousman, PhD
role: PRINCIPAL_INVESTIGATOR
References: