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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date May 2024
Source University of Calgary
Contact Laina McAusland, MSc
Phone 403-210-6353
Email psychpgxlab@ucalgary.ca
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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