Personalized Pharmacotherapy Using Pharmacogenetics in Veterans

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About 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 accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pharmacogenetics Testing

    Genetic

    Genetic test to determine individual genetic compatibility with multiple pharmaceutical drug classes to determine best outcomes for prescription drug treatment.

Treatment groups

155 Participants
are divided into 3 treatment groups
Group A: Mental Health ProviderNo intervention 0 interventions
Group B: Patient with Pharmacogenetic TestingExperimental treatment 1 intervention
Group C: Patient without Pharmacogenetic TestingNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

PHQ-9 - Patient Health Questionnaire 9

Objectifies degree of depression severity

Time frame
5 minutes
2

GAD-7 - General Anxiety Disorder-7

Measures severity of anxiety

Time frame
5 minutes
3

PCL-5 - Posttraumatic Stress Disorder Checklist - 5

A 20-item self-report tool that corresponds to the 20 symptoms listed in the DSM-V

Time frame
5 minutes
4

OQ-45 - Outcome Questionnaire 45

A 45-item multiple-choice self-report inventory used to measure psychotherapy progress in adult patients

Time frame
10 minutes

Secondary outcomes

Other outcomes

Sponsors and contacts

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