Recruiting

Pharmacogenetics

Sponsor:

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

Code:

NCT06335043

Conditions

Pharmacogenetic Testing to Determine Pharmacological Treatment in PTSD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Pharmacogenetics Testing

Study Details

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.

Conditions

Pharmacogenetic Testing to Determine Pharmacological Treatment in PTSD

Study ID

NCT06335043

Start date

Apr 25, 2024

Status verified date

Mar, 2025

Completion date

Apr 25, 2027

Anticipated

Primary completion date

Apr 25, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

155 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Mental Health Provider

Mental health provider's thoughts on pharmacogenetic testing for treatment planning and changes to treatment planning.

experimental: Patient with Pharmacogenetic Testing

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.

no intervention: Patient without Pharmacogenetic Testing

For patient participants who opt-out to pharmacogenetic testing will be followed to see if treatment course is maintained.

Interventions

Pharmacogenetics Testing

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

Primary outcome measure

  • PHQ-9 - Patient Health Questionnaire 9 [ Time Frame: 5 minutes ]
  • GAD-7 - General Anxiety Disorder-7 [ Time Frame: 5 minutes ]
  • PCL-5 - Posttraumatic Stress Disorder Checklist - 5 [ Time Frame: 5 minutes ]
  • OQ-45 - Outcome Questionnaire 45 [ Time Frame: 10 minutes ]
  • Pharmacological Side Effect Measure [ Time Frame: 10 minutes ]
  • Electronic Medical Record Extraction Measure [ Time Frame: 10 minutes ]

Central Contacts and Locations

Central contacts

Locations

MacDonald Franklin OSI Research and Innovation Centre

Recruiting

London, Ontario, Canada, N6C 0A7

Contacts

More Information

Sponsor

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

Last update posted

Mar 13, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2025-03-13.