Pharmacogenomics-Supported Psychotropic Prescribing Trial (PGx-SUPPORT)

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

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

Study Overview

• Status: Recruiting
• Conditions: Mental Disorder; Pharmacogenetics; Effectiveness; Adverse Drug Reaction (ADR)
• Intervention / Treatment: Diagnostic test: Pharmacogenetic Testing

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

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdullah Al Maruf, BPharm, MPharm, PhD; Phone Number: 204-318-2575; Email: abdullah.maruf@umanitoba.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0T5
      • Recruiting
      • University of Manitoba College of Pharmacy
      • Contact: Abdullah Al Maruf, PhD, M.Pharm, B.Pharm; Phone Number: 204-318-2575; Email: abdullah.maruf@umanitoba.ca
      • Contact: Mahin Hasan, MSc, BSc; Email: hasanm33@myumanitoba.ca
    • Winnipeg, Manitoba, Canada, R3C 3H8
      • Not yet recruiting
      • Shared Health Facilities
      • Contact: Abdullah Al Maruf, PhD, M.Pharm, B.Pharm; Phone Number: 204-318-2575; Email: abdullah.maruf@umanitoba.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Testing Acceptibility	Acceptability will be measured via a four-item patient satisfaction survey three months after the testing and a two-item clinician satisfaction survey after discharge. Responses will be recorded on a five-point Likert scale (1 = very dissatisfied to 5 = very satisfied).	3 months after after baseline.
Implementation Practicality	Practicality will be measured by the mean and median testing turnaround time (i.e., test ordering to return of results).	Up to 3 Months
Implementation Feasibility	Implementation will be measured using a two-item clinician self-report questionnaire that asks about using testing results in the prescribing decision-making process. These will be Yes/No questions, with more "yes" responses indicating higher usefulness and interest in using the test in clinical practice.	Patient discharge date [within 3 months of baseline].
Test Demands	Demand will be measured by the total number of referrals to the study and by a one-item clinician self-report questionnaire asking about intent to use the testing in the future. Responses will be recorded on a five-point Likert scale (1 = very unlikely to 5 = very likely).	Patient discharge date [within 3 months of baseline].

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression Scale (CGI) - Severity	1 = normal, 7 = among the most extremely ill	Baseline
Clinical Global Impression Scale (CGI) - Improvement	Assesses the overall change in the patient's condition compared to baseline, on a 7-point scale (1 = very much improved, 7 = very much worse).	3 months after baseline.
Brief Psychiatric Rating Scale (BPRS)	The rater enters a number for each symptom construct, ranging from 1 (not present) to 7 (extremely severe).	Baseline and patient discharge date, within 3 months.
DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure - Adult	This adult version of the measure consists of 23 questions that assess 13 psychiatric domains, including depression, anger, mania, anxiety, somatic symptoms, suicidal ideation, psychosis, sleep problems, memory, repetitive thoughts and behaviors, dissociation, personality functioning, and substance use. Each item on the measure is rated on a 5-point scale (0=none or not at all; 1=slight or rare, less than a day or two; 2=mild or several days; 3=moderate or more than half the days; and 4=severe or nearly every day).	Baseline and 3 months after baseline.
General Anxiety Disorder-7 (GAD-7)	This is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety	Baseline and 3 months after baseline.
Patient Health Questionnaire-9 (PHQ-9)	The PHQ-9 asks patients about the frequency with which they have experienced certain symptoms over the past two weeks, using a four-point scale (0 = "not at all" to 3 = "nearly every day"). The total score, ranging from 0 to 27, indicates the severity of depression, with higher scores suggesting more severe symptoms. Scoring: 0-4: Minimal or no symptoms 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression 20 or higher: Severe depression	Baseline and 3 months after baseline.
Altman Self-Rating Mania Scale (ASRM) - Adult	Each item on the measure is rated on a 5-point scale (i.e., 1 to 5) with the response categories having different anchors depending on the item. The ASRM score range from 5 to 25 with higher scores indicating greater severity of manic symptoms.	Baseline and 3 months after baseline.
The Early Psychosis Screener (EPS-26)	The EPS-26 consists of 26 questions that assess for symptoms and experiences associated with psychosis. A higher score on the EPS-26 suggests a greater likelihood of being at risk for psychosis.	Baseline and 3 months after baseline.
Frequency, Intensity, Burden of Side Effects Rating (FIBSER)	It measures three dimensions: the frequency of side effects, the intensity of these side effects, and the burden they impose on daily functioning. Each dimension is rated on a Likert scale, ranging from 0 to 6, where higher scores indicate greater severity and difficulty caused by side effects.	Baseline (if applicable) and 3 months after baseline.
Healthcare Utlization	Changes in healthcare utilization (including inpatient length of stay) will be measured using a ten-item patient self-report mental health resource use questionnaire, medical charts, and administrative data records six months before and after the participant enrolled in the study.	1 year

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Health Sciences Centre, Winnipeg, Manitoba; University of Calgary; Winnipeg Regional Health Authority; Shared Health Manitoba
• Investigators: Principal Investigator: Abdullah Al Maruf, PhD, M.Pharm., B.Pharm, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: September 1, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Psychosis; OCD; Mental Health; Anxiety; Bipolar Disorder; Psychiatry; Adult; Pharmacogenetics; mental illness
• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Behavioral Symptoms; Chemically-Induced Disorders; Mood Disorders; Behavior; Personal Satisfaction; Psychotic Disorders; Anxiety Disorders; Depression; Bipolar Disorder; Mental Disorders; Drug-Related Side Effects and Adverse Reactions; Psychological Well-Being; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Genetic Testing; Genetic Techniques; Genetic Services; Diagnostic Services; Pharmacogenomic Testing
• Other Study ID Numbers: HS26637 (HS2024:279)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No