Pharmacogenetic Supported Prescribing in Kids

Mental Health Impairment Clinical Trial

— PGx-SParK  

Official title:

Pharmacogenetic Supported Prescribing in Kids

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04797364
• Other study ID #: REB20-0900
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2021
• Est. completion date: July 1, 2025

Study information

• Verified date: November 2022
• Source: University of Calgary
• Contact: Laina McAusland, MSc
• Phone: 403-210-6353
• Email: psychpgxlab[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Health Impairment

Intervention

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

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse drug reactions	Relative change in adverse drug reaction frequency	6-months
Primary	Symptom severity	Relative change in symptom severity	6-months
Secondary	Healthcare utilization	Relative change in healthcare utilization	6-months