Clinical trial NCT06929533: Pharmacogenomics-Supported Psychotropic Prescribing Trial
Official title: Pharmacogenomics-Supported Psychotropic Prescribing Trial (PGx-SUPPORT): A Pilot Study on Inpatient Mental Health Units in Manitoba
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mental Disorder
Pharmacogenetics
Adverse Drug Reaction (ADR)
Effectiveness
Keywords: Adult
Mental Health
Psychiatry
Pharmacogenetics
Depression
Anxiety
OCD
Psychosis
Bipolar Disorder
mental illness
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: University of Calgary
name: Shared Health Manitoba
name: Winnipeg Regional Health Authority
name: Health Sciences Centre, Winnipeg, Manitoba
First posted: 2025-04-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Testing Acceptibility
timeFrame: 3 months after after baseline.
measure: Implementation Practicality
timeFrame: Up to 3 Months
measure: Implementation Feasibility
timeFrame: Patient discharge date [within 3 months of baseline].
measure: Test Demands
timeFrame: Patient discharge date [within 3 months of baseline].
Secondary outcomes:
measure: Clinical Global Impression Scale (CGI) - Severity
timeFrame: Baseline
measure: Clinical Global Impression Scale (CGI) - Improvement
timeFrame: 3 months after baseline.
measure: Brief Psychiatric Rating Scale (BPRS)
timeFrame: Baseline and patient discharge date, within 3 months.
measure: DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure - Adult
timeFrame: Baseline and 3 months after baseline.
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline and 3 months after baseline.
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline and 3 months after baseline.
measure: Altman Self-Rating Mania Scale (ASRM) - Adult
timeFrame: Baseline and 3 months after baseline.
measure: The Early Psychosis Screener (EPS-26)
timeFrame: Baseline and 3 months after baseline.
measure: Frequency, Intensity, Burden of Side Effects Rating (FIBSER)
timeFrame: Baseline (if applicable) and 3 months after baseline.
measure: Healthcare Utlization
timeFrame: 1 year
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Shared Health Facilities
state: Manitoba
city: Winnipeg
country: Canada
facility: University of Manitoba College of Pharmacy
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Abdullah Al Maruf, PhD, M.Pharm., B.Pharm
role: PRINCIPAL_INVESTIGATOR
References: