Pharmacogenetic Supported Prescribing in Kids

  • STATUS
    Recruiting
  • End date
    Jul 1, 2025
  • participants needed
    6000
  • sponsor
    University of Calgary
Updated on 23 March 2021

Summary

Implementation of pharmacogenetic testing for children and adolescents aged 7-17 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.

Details
Condition Mental Health Impairment
Treatment Pharmacogenetic testing
Clinical Study IdentifierNCT04797364
SponsorUniversity of Calgary
Last Modified on23 March 2021

Eligibility

Yes No Not Sure

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 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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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