MacDonald Franklin OSI Research and Innovation Centre
London, Ontario, N6C 0A7, Canada
Location status: Recruiting
Recruiting
NCT Number: NCT06335043
Personalized Pharmacotherapy Using Pharmacogenetics in Veterans
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Pharmacogenetics Testing
GeneticGenetic test to determine individual genetic compatibility with multiple pharmaceutical drug classes to determine best outcomes for prescription drug treatment.
Primary outcomes
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PHQ-9 - Patient Health Questionnaire 9
Time frame: 5 minutes
Objectifies degree of depression severity
-
GAD-7 - General Anxiety Disorder-7
Time frame: 5 minutes
Measures severity of anxiety
-
PCL-5 - Posttraumatic Stress Disorder Checklist - 5
Time frame: 5 minutes
A 20-item self-report tool that corresponds to the 20 symptoms listed in the DSM-V
-
OQ-45 - Outcome Questionnaire 45
Time frame: 10 minutes
A 45-item multiple-choice self-report inventory used to measure psychotherapy progress in adult patients
-
Pharmacological Side Effect Measure
Time frame: 10 minutes
To determine if the participant is experiencing any new or worsening or continuing side effects related to prescription medications
-
Electronic Medical Record Extraction Measure
Time frame: 10 minutes
To determine trial and error attempts with pharmacological prescriptions in an attempt to minimize and/or control symptoms
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Other
Registry information
Official study title
Personalized Pharmacotherapy Using Pharmacogenetics in Veterans Seeking Treatment for Mental Health
Acronym: PGx
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Mar 28, 2024
- Registry last updated
- Mar 13, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.