Personalized Pharmacotherapy Using Pharmacogenetics in Veterans (PGx)

Personalized Pharmacotherapy Using Pharmacogenetics in Veterans Seeking Treatment for Mental Health

This study is an observational clinical trial aimed at to evaluate the use of pharmacogenetic testing (PGx) for mental health treatment in members and Veterans of the CAF and RCMP patient population as well as the attitudes of both St. Joseph's OSI Clinic Psychiatrists and patients towards PGx. Both OSI Clinic Psychiatrists participants and patient participants will be administered a brief demographic survey in addition to a survey examining their views on, and current knowledge of PGx. Patient participants will have an opportunity to opt-in to or opt-out of receiving PGx. For patient participants who opt-in to PGx (PGx-guided treatment group), a report summarizing the PGx results will be sent to each patient participants' respective OSI Clinic Psychiatrist, alongside a questionnaire that captures the OSI Clinic Psychiatrist participant's treatment planning and changes to treatment planning. Where applicable, past treatment data from patient participants acquired at the St. Joseph's OSI Clinic will be used to identify the number of prior medication changes. Patient participants who opt-out of PGx but continue to receive pharmacologic care at the St. Joseph's OSI Clinic will act as a standard care comparator treatment group. Patient participant's outcomes including PTSD, depression and anxiety severity, and medication-related side effects, will be assessed until the patient participant is discharged from the OSI Clinic or after 24 weeks, whichever comes first. All patient participants, regardless of their study treatment group, will have their symptomatology collected via standard care data collection protocol (Client Reported Outcomes Monitoring Information System (CROMIS) and electronic medical records (EMR)); a self-report assessing the presence of side effects will be completed via Lawson REDCap. OSI Clinic Psychiatrist participants and patient participants will be asked to complete a virtual exit interview at the end of their participation.

Study Overview

• Status: Recruiting
• Conditions: Pharmacogenetic Testing to Determine Pharmacological Treatment in PTSD
• Intervention / Treatment: Genetic: Pharmacogenetics Testing

• Study Type: Interventional
• Enrollment (Estimated): 155
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natalie Ein, PhD; Phone Number: 416-573-9047; Email: natalie.ein@sjhc.london.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6C 0A7
      • Recruiting
      • MacDonald Franklin OSI Research and Innovation Centre
      • Contact: Natalie Ein, PhD; Phone Number: 416-573-9047; Email: natalie.ein@sjhc.london.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Provider participant:

  • Are at least 18 years of age;
  • Speak and write English;

  • Currently working as an OSI Clinic Psychiatrist at the London St. Joseph's OSI Clinic.

    • Psychiatrist with an active caseload of patients being treated for OSIs.

• Patient participant:

  • Veteran (patient) CAF or RCMP member;
  • Are at least 18 years of age;
  • Are a current patient at the London St. Joseph's OSI Clinic;
  • Current diagnosis of an OSI;
  • Speak and write English;
  • Consents to the use of CROMIS data for the purpose of this study; and
  • Consents to the use of prior OSI Clinic data for research purposes (if you have been a patient at the OSI Clinic prior to this study, the research team will use past OSI Clinic data to observe changes over time).

Exclusion Criteria:

• Participants (provider or patients) who are unable to, or do not, provide informed consent for participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Mental Health Provider; Mental health provider's thoughts on pharmacogenetic testing for treatment planning and changes to treatment planning.
Experimental: Patient with Pharmacogenetic Testing; For patient participants who opt-in to pharmacogenetic testing, a report summarizing the pharmacogenetic testing results will be sent to each patient participants' respective mental health provider.	Genetic: Pharmacogenetics Testing; Genetic test to determine individual genetic compatibility with multiple pharmaceutical drug classes to determine best outcomes for prescription drug treatment.
No Intervention: Patient without Pharmacogenetic Testing; For patient participants who opt-out to pharmacogenetic testing will be followed to see if treatment course is maintained.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PHQ-9 - Patient Health Questionnaire 9	Objectifies degree of depression severity	5 minutes
GAD-7 - General Anxiety Disorder-7	Measures severity of anxiety	5 minutes
PCL-5 - Posttraumatic Stress Disorder Checklist - 5	A 20-item self-report tool that corresponds to the 20 symptoms listed in the DSM-V	5 minutes
OQ-45 - Outcome Questionnaire 45	A 45-item multiple-choice self-report inventory used to measure psychotherapy progress in adult patients	10 minutes
Pharmacological Side Effect Measure	To determine if the participant is experiencing any new or worsening or continuing side effects related to prescription medications	10 minutes
Electronic Medical Record Extraction Measure	To determine trial and error attempts with pharmacological prescriptions in an attempt to minimize and/or control symptoms	10 minutes

Collaborators and Investigators

• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2024
• Primary Completion (Estimated): April 25, 2027
• Study Completion (Estimated): April 25, 2027

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 119245

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