Pharmacogenomics-Supported Psychotropic Prescribing Trial

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06929533
• Lead Sponsor: University of Manitoba

Brief Summary

Investigate the feasibility and utility of implementing pharmacogenetic testing for adults (aged 18 and older) seeking care for mental illness in inpatient psychiatry clinics 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. Although there is some evidence that PGx testing may improve patient outcomes and reduce the length of hospital stays, other studies have not found any benefit of PGx testing on inpatient units. Notably, most inpatient studies to date have been conducted outside of Canada, mainly in the USA and Europe. PGx testing is not offered on inpatient units in Manitoba. 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 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 inpatient psychiatry clinics 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 Timeline

• Study First Submitted: 2025-03-27
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-14
• Last Update Submitted: 2025-04-14
• Study First Posted: 2025-04-16
• Last Update Posted: 2025-04-16
• Study Start: 2025-06-01
• Primary Completion: 2028-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Presented for services within inpatient units in Manitoba
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Testing Acceptibility	3 months after after baseline.	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).
Implementation Practicality	Up to 3 Months	Practicality will be measured by the mean and median testing turnaround time (i.e., test ordering to return of results).
Implementation Feasibility	Patient discharge date [within 3 months of baseline].	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.
Test Demands	Patient discharge date [within 3 months of baseline].	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).

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression Scale (CGI) - Severity	Baseline	1 = normal, 7 = among the most extremely ill
Patient Health Questionnaire-9 (PHQ-9)	Baseline and 3 months after baseline.	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
Clinical Global Impression Scale (CGI) - Improvement	3 months after baseline.	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).
Brief Psychiatric Rating Scale (BPRS)	Baseline and patient discharge date, within 3 months.	The rater enters a number for each symptom construct, ranging from 1 (not present) to 7 (extremely severe).
DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure - Adult	Baseline and 3 months after baseline.	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).
Altman Self-Rating Mania Scale (ASRM) - Adult	Baseline and 3 months after baseline.	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.
General Anxiety Disorder-7 (GAD-7)	Baseline and 3 months after baseline.	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
The Early Psychosis Screener (EPS-26)	Baseline and 3 months after baseline.	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.
Frequency, Intensity, Burden of Side Effects Rating (FIBSER)	Baseline (if applicable) and 3 months after baseline.	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.
Healthcare Utlization	1 year	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.

Trial Locations

Locations (2)

Shared Health Facilities; 🇨🇦 Winnipeg, Manitoba, Canada

University of Manitoba College of Pharmacy; 🇨🇦 Winnipeg, Manitoba, Canada