ClinicalTrials.gg
RecruitingNCT06335043PGxUpdated Sep 23, 2026

Personalized Pharmacotherapy Using Pharmacogenetics in Veterans

An interventional study of Pharmacogenetics Testing in Pharmacogenetic Testing to Determine Pharmacological Treatment in PTSD, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
155
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 125 studies in Stress Disorders, Post-Traumatic with a site in Canada — 32 open to participants now, 40 under way, 2 of them phase 3. Stress Disorders, Post-Traumatic · Canada.

Planned enrollment
13th of 111
155 · median 54
Started
2024
with 6 others
No phase
82 of 125
19 open now
Primary completion
2027-04
later than 23 of 39 live
Registered
104th of 125
by date
Lead sponsor
8 of 125
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Among the 125 studies in Stress Disorders, Post-Traumatic with a site in Canada, this one is the 13th largest by planned enrollment of the 111 interventional ones that give a count, is one of 7 that started in 2024, is one of 82 with no phase, reaches primary completion later than 23 of the 39 other live ones, and was the 104th registered.

Stress Disorders, Post-Traumatic

2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.

This study's planned enrollment of 155 is above the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Open to participants now

32 of the 125 studies in Stress Disorders, Post-Traumatic with a site in Canada are open now, in 2 countries. Each count lists the studies.

All 32 open studies →

Where they have run

Who these studies take

Of the 417 Stress Disorders, Post-Traumatic studies recruiting now, 186 (45%) set no upper age limit and 205 (49%) stop at 75 or younger; 63 take children under 18; 89 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 125 studies in Stress Disorders, Post-Traumatic with a site in Canada, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Pharmacogenetic Testing to Determine Pharmacological Treatment in PTSD
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Participants (provider or patients) who are unable to, or do not, provide for participation.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
155 participants (estimated)

Study 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.

    Genetic: Pharmacogenetics Testing

  • 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

  • GeneticPharmacogenetics Testing

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

06

What researchers measure

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

  5. Pharmacological Side Effect Measure

    To determine if the participant is experiencing any new or worsening or continuing side effects related to prescription medications

    Time frame: 10 minutes

  6. Electronic Medical Record Extraction Measure

    To determine trial and error attempts with pharmacological prescriptions in an attempt to minimize and/or control symptoms

    Time frame: 10 minutes

07

Study locations

1 of 1 sites recruiting
  • MacDonald Franklin OSI Research and Innovation Centre
    London, Ontario N6C 0A7, Canada
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2024 (actual). Primary completion is estimated for Apr 2027, 36 months after the start.

Of 1,064 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 36 months is close to that.

Counting every sponsor, half of 1,092 studies reached it within 34 months; a quarter within 17 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 13, 2024
First posted
Mar 28, 2024
StartActual
Apr 25, 2024
Primary completionEst.
Apr 25, 2027
CompletionEst.
Apr 25, 2027
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06335043
Responsible party
Don Richardson (Scientific Director, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's) — Principal investigator
First posted
Mar 28, 2024
Start date
Apr 25, 2024
Primary completion
Apr 25, 2027 (estimated)
Completion
Apr 25, 2027 (estimated)
Last update
Sep 23, 2026

Study contacts

Natalie Ein, PhD
Contact
natalie.ein@sjhc.london.on.ca
416-573-9047

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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