Pharmacogenomics-Supported Psychotropic Prescribing Trial (PGx-SUPPORT)

University of Manitoba

Status: Enrolling

Conditions: Effectiveness; Mental Disorder; Adverse Drug Reaction (ADR); Pharmacogenetics

Treatments: Diagnostic Test: Pharmacogenetic Testing

Study type: Interventional

Funder types: Other

Identifiers

NCT06929533

HS26637 (HS2024:279)

Details and patient eligibility

About

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

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 years or older
• The initiation, change, dose adjustment, or augmentation of psychotropic medication(s) is indicated
• The treating clinician thinks PGx testing can benefit and refers the patient to the study

Exclusion criteria

• Unwillingness to donate saliva samples for genetic analysis
• History of liver or bone marrow (hematopoietic cell) transplantation
• PGx testing results are already available
• No personal health identification number (PHIN) is available

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Pharmacogenetic Testing

Experimental group

Description:

Pharmacogenetic testing panel (CYP2C19, CYP2D6, CYP2B6, CYP3A4, CYP3A5, CYP2C9, CYP4F2, DPYD, HLA-A, HLA-B, NUDT15, SLCO1B1, TPMT, VKORC1, 2C Cluster, UGT1A1)

Treatment:

Diagnostic Test: Pharmacogenetic Testing