Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2026-01-01 @ 2:12 AM
Study NCT ID:
NCT06929533
Status:
RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacogenomics-Supported Psychotropic Prescribing Trial
Sponsor:
University of Manitoba
Organization:
Study Overview
Official Title:
Pharmacogenomics-Supported Psychotropic Prescribing Trial (PGx-SUPPORT): A Pilot Implementation Study in Manitoba
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PGx-SUPPORT
Brief 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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: