Pharmacogenomics-Supported Psychotropic Prescribing Trial
NCT ID: NCT06929533
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2025-07-01
2030-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Pharmacogenetic Testing
Pharmacogenetic testing panel (CYP2C19, CYP2D6, CYP2B6, CYP3A4, CYP3A5, CYP2C9, CYP4F2, DPYD, HLA-A, HLA-B, NUDT15, SLCO1B1, TPMT, VKORC1, 2C Cluster, UGT1A1)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* History of liver or bone marrow (hematopoietic cell) transplantation
* PGx testing results are already available
* No personal health identification number (PHIN) is available
18 Years
ALL
No
Sponsors
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University of Calgary
OTHER
Shared Health Manitoba
UNKNOWN
Winnipeg Regional Health Authority
OTHER
Health Sciences Centre, Winnipeg, Manitoba
OTHER
University of Manitoba
OTHER
Responsible Party
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Abdullah Al Maruf
Assistant Professor
Principal Investigators
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Abdullah Al Maruf, PhD, M.Pharm., B.Pharm
Role: PRINCIPAL_INVESTIGATOR
University of Manitoba
Locations
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Shared Health Facilities
Winnipeg, Manitoba, Canada
University of Manitoba College of Pharmacy
Winnipeg, Manitoba, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HS26637 (HS2024:279)
Identifier Type: -
Identifier Source: org_study_id
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