155 Participants Needed

Genetic Testing for Mental Health

(PGx Trial)

NE
Overseen ByNatalie Ein, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Lawson Health Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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

This trial is for current patients at the London St. Joseph's OSI Clinic who are Veterans or RCMP members, at least 18 years old, with a diagnosis of an Operational Stress Injury (OSI) and have never received pharmacogenetic testing. Psychiatrists working there with active caseloads can also participate.

Inclusion Criteria

Patient participant: Are a current patient at the London St. Joseph's OSI Clinic
Patient participant: Current diagnosis of an OSI
Patient participant: Consents to the use of CROMIS data for the purpose of this study
See 5 more

Exclusion Criteria

I am able to and have provided informed consent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants opt-in to pharmacogenetic testing or continue with standard pharmacologic care

24 weeks
Regular visits as per standard care protocol

Follow-up

Participants are monitored for PTSD, depression, anxiety severity, and medication-related side effects until discharge or after 24 weeks

24 weeks
Virtual exit interview at the end of participation

Treatment Details

Interventions

  • Pharmacogenetics Testing
Trial Overview The study observes how genetic testing (pharmacogenetics) influences mental health treatment in veterans and their attitudes towards it. It compares outcomes between those opting for PGx-guided treatment and those receiving standard care without genetic testing.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Patient with Pharmacogenetic TestingExperimental Treatment1 Intervention
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.
Group II: Patient without Pharmacogenetic TestingActive Control1 Intervention
For patient participants who opt-out to pharmacogenetic testing will be followed to see if treatment course is maintained.
Group III: Mental Health ProviderActive Control1 Intervention
Mental health provider's thoughts on pharmacogenetic testing for treatment planning and changes to treatment planning.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lawson Health Research Institute

Lead Sponsor

Trials
684
Recruited
432,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials
686
Recruited
427,000+

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

Lead Sponsor

Trials
678
Recruited
421,000+

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

Lead Sponsor

Trials
668
Recruited
424,000+
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