NCT06929533

Pharmacogenomics-Supported Psychotropic Prescribing Trial

Pharmacogenomics-Supported Psychotropic Prescribing Trial (PGx-SUPPORT): A Pilot Implementation Study in Manitoba

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Investigate the feasibility and utility of implementing pharmacogenetic testing for adults (aged 18 and older) seeking care for mental illness in Manitoba.

Detailed description

Background and Rationale: Pharmacogenomic (PGx) testing utilizes genetic information as a surrogate marker of a person's ability to process and react to drugs. This information can be used to inform medication selection and dosing, reducing the number of trials needed to choose a suitable medicine. For Manitoba healthcare providers, the only access to psychiatric PGx testing is through commercial providers, costing patients $200 to $2,300. To the best of our knowledge, no study in Manitoba has previously evaluated the feasibility of PGx testing in adult patients seeking care for mental illness. RESEARCH OBJECTIVES: We aim to investigate the feasibility and utility of implementing PGx testing in Manitoba for adult patients seeking care for mental illness. Primary Outcome and Measures: Feasibility will be measured along four dimensions: * Acceptability (satisfaction surveys - patient \& clinician) * Practicality (testing turnaround time) * Implementation (clinicians' self-reported use of testing results in the prescribing decision-making process) * Demand (number of referrals, clinicians' self-reported intent to use testing in the future) Secondary Outcomes and Measures: * Changes in global functioning and symptom severity \[Clinical Global Impression (CGI) - Severity and Improvement; Brief Psychiatric Rating Scale (BPRS); DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure; Patient Health Questionnaire-9 (PHQ-9); General Anxiety Disorder-7 (GAD-7); Altman Self-Rating Mania Scale (ASRM); Early Psychosis Screener (EPS-26)\] * Adverse drug experience \[Frequency, Intensity, Burden of Side Effects Rating (FIBSER)\] * Impact of PGx testing \[Changes in medication prescribing and dispensing patterns; changes in healthcare utilization (e.g., inpatient length of stay, mental health resource use, and utilization of healthcare services) Expected Outcomes: The findings from the proposed study will inform policymakers and facilitate decision-making and priority-setting related to implementing PGx-based psychotropic prescribing policies in Manitoba

Conditions

• Mental Disorder
• Pharmacogenetics
• Adverse Drug Reaction (ADR)
• Effectiveness

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Pharmacogenetic Testing	Participants will donate a 1ml (one-fifth of a 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) 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 patient's current and future care.

Timeline

• Start date: 2025-07-01
• Primary completion: 2028-12-31
• Completion: 2030-12-31
• First posted: 2025-04-16
• Last updated: 2025-09-08

Locations

2 sites across 1 country: Canada