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Clinical Trials/NCT06335043
NCT06335043
Recruiting
Not Applicable

Personalized Pharmacotherapy Using Pharmacogenetics in Veterans Seeking Treatment for Mental Health

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's1 site in 1 country155 target enrollmentApril 25, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pharmacogenetic Testing to Determine Pharmacological Treatment in PTSD
Sponsor
London Health Sciences Centre OR Lawson Research Institute of St. Joseph's
Enrollment
155
Locations
1
Primary Endpoint
OQ-45 - Outcome Questionnaire 45
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 25, 2024
End Date
April 25, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Don Richardson

Scientific Director

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

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;

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

GAD-7 - General Anxiety Disorder-7

Time Frame: 5 minutes

Measures severity of anxiety

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

PHQ-9 - Patient Health Questionnaire 9

Time Frame: 5 minutes

Objectifies degree of depression severity

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

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

Study Sites (1)

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