Pharmacogenetic Supported Prescribing in Kids

NCT ID: NCT04797364

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 6000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-18
• Study Completion Date: 2025-07-01

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.

Conditions

Mental Health Impairment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Pharmacogenetic Testing

Pharmacogenetic testing panel (CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A5, NUDT15, SLCO1B1, TPMT, VKORC1)

Group Type: EXPERIMENTAL

Pharmacogenetic Testing

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Chad Bousman

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chad Bousman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

University of Calgary

Calgary, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Laina McAusland, MSc

Role: CONTACT

psychpgxlab@ucalgary.ca

403-210-6353

Facility Contacts

Laina McAusland, MSc

Role: primary

psychpgxlab@ucalgary.ca

403-210-6353

References

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.

Reference Type: DERIVED

PMID: 38377520 (View on PubMed)

Other Identifiers

REB20-0900

Identifier Type: -

Identifier Source: org_study_id