NCT06335043 Personalized Pharmacotherapy Using Pharmacogenetics in Veterans
| NCT ID | NCT06335043 |
| Status | Recruiting |
| Phase | — |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
| Condition | Pharmacogenetic Testing to Determine Pharmacological Treatment in PTSD |
| Study Type | INTERVENTIONAL |
| Enrollment | 155 participants |
| Start Date | 2024-04-25 |
| Primary Completion | 2027-04-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 155 participants in total. It began in 2024-04-25 with a primary completion date of 2027-04-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06335043 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pharmacogenetic Testing to Determine Pharmacological Treatment in PTSD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06335043 currently recruiting?
Yes, NCT06335043 is actively recruiting participants. Contact the research team at natalie.ein@sjhc.london.on.ca for enrollment information.
Where is the NCT06335043 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT06335043 clinical trial?
NCT06335043 is sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. The trial plans to enroll 155 participants.
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