Pharmacogenetic Supported Prescribing in Kids
PGx-SParK
1 other identifier
interventional
6,000
1 country
1
Brief Summary
Implementation of pharmacogenetic testing for children and adolescents aged 6-24 who are starting or changing psychiatric medication.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 18, 2021
CompletedFirst Submitted
Initial submission to the registry
March 9, 2021
CompletedFirst Posted
Study publicly available on registry
March 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedMay 9, 2024
May 1, 2024
4.5 years
March 9, 2021
May 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adverse drug reactions
Relative change in adverse drug reaction frequency
6-months
Symptom severity
Relative change in symptom severity
6-months
Secondary Outcomes (1)
Healthcare utilization
6-months
Study Arms (1)
Pharmacogenetic Testing
EXPERIMENTALPharmacogenetic testing panel (CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A5, NUDT15, SLCO1B1, TPMT, VKORC1)
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Calgary
Calgary, Alberta, T2N 4N1, Canada
Related Publications (1)
Bharthi K, Zuberi R, Maruf AA, Shaheen SM, McCloud R, Heintz M, McAusland L, Arnold PD, Bousman CA. Impact of Cytochrome P450 Genetic Variation on Patient-Reported Symptom Improvement and Side Effects Among Children and Adolescents Treated with Fluoxetine. J Child Adolesc Psychopharmacol. 2024 Feb;34(1):21-27. doi: 10.1089/cap.2023.0039.
PMID: 38377520DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chad Bousman, PhD
University of Calgary
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 9, 2021
First Posted
March 15, 2021
Study Start
January 18, 2021
Primary Completion
July 1, 2025
Study Completion
July 1, 2025
Last Updated
May 9, 2024
Record last verified: 2024-05