Pharmacogenetic Testing to Determine Pharmacological Treatment in PTSDPGxNCT06335043
Personalized Pharmacotherapy Using Pharmacogenetics in Veterans
A study testing Pharmacogenetics Testing in people with Pharmacogenetic Testing to Determine Pharmacological Treatment in PTSD, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pharmacogenetic Testing to Determine Pharmacological Treatment in PTSD
- What is being tested?
- Pharmacogenetics Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteCanada
- Study dates
- 25 Apr 2024to 25 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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).
Who cannot join
- Participants (provider or patients) who are unable to, or do not, provide informed consent for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
MacDonald Franklin OSI Research and Innovation Centre
London, Ontario, N6C 0A7
Natalie Ein, PhD, 416-573-9047, natalie.ein@sjhc.london.on.ca
About this study
Official title: Personalized Pharmacotherapy Using Pharmacogenetics in Veterans Seeking Treatment for Mental Health
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.
- Being tested
- Pharmacogenetics Testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenetics TestingGenetic
Genetic test to determine individual genetic compatibility with multiple pharmaceutical drug classes to determine best outcomes for prescription drug treatment.
| Study group | Role | What they receive |
|---|---|---|
| Mental Health Provider | No intervention | Mental health provider's thoughts on pharmacogenetic testing for treatment planning and changes to treatment planning. |
| Patient with Pharmacogenetic Testing | Experimental | 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. Receives: Genetic: Pharmacogenetics Testing |
| Patient without Pharmacogenetic Testing | No intervention | For patient participants who opt-out to pharmacogenetic testing will be followed to see if treatment course is maintained. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PHQ-9 - Patient Health Questionnaire 9
Objectifies degree of depression severity
Measured: 5 minutes
GAD-7 - General Anxiety Disorder-7
Measures severity of anxiety
Measured: 5 minutes
PCL-5 - Posttraumatic Stress Disorder Checklist - 5
A 20-item self-report tool that corresponds to the 20 symptoms listed in the DSM-V
Measured: 5 minutes
OQ-45 - Outcome Questionnaire 45
A 45-item multiple-choice self-report inventory used to measure psychotherapy progress in adult patients
Measured: 10 minutes
Pharmacological Side Effect Measure
To determine if the participant is experiencing any new or worsening or continuing side effects related to prescription medications
Measured: 10 minutes
Electronic Medical Record Extraction Measure
To determine trial and error attempts with pharmacological prescriptions in an attempt to minimize and/or control symptoms
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start25 Apr 2024
- Primary completion25 Apr 2027 (estimated)
- Study completion25 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacogenetic Testing to Determine Pharmacological Treatment in PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Don Richardson, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335043
- Sponsor's protocol ID
- 119245
- Acronym
- PGx
- Status last verified
- Sep 2026
- First submitted
- 13 Mar 2024
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Pharmacotherapy Using Pharmacogenetics in Veterans Seeking Treatment for Mental Health
- ClinicalTrials.gov ID
- NCT06335043
- Acronym / sponsor ID
- PGx / 119245
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 25 Apr 2027 (estimated)
- Study completion
- 25 Apr 2027 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mental Health Provider | No intervention | –Mental health provider's thoughts on pharmacogenetic testing for treatment planning and changes to treatment planning. |
| Patient with Pharmacogenetic Testing | Experimental | Genetic: Pharmacogenetics TestingFor 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. |
| Patient without Pharmacogenetic Testing | No intervention | –For patient participants who opt-out to pharmacogenetic testing will be followed to see if treatment course is maintained. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Provider participant:
- Patient participant:
Key exclusion criteria (1 listed)
- Participants (provider or patients) who are unable to, or do not, provide informed consent for participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacogenetics TestingGenetic test to determine individual genetic compatibility with multiple pharmaceutical drug classes to determine best outcomes for prescription drug treatment. | Genetic | Patient with Pharmacogenetic Testing |
Primary outcome
PHQ-9 - Patient Health Questionnaire 9
Time frame: 5 minutes
Objectifies degree of depression severity
GAD-7 - General Anxiety Disorder-7
Time frame: 5 minutes
Measures severity of anxiety
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacogenetics Testing in people with Pharmacogenetic Testing to Determine Pharmacological Treatment in PTSD, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalie Ein, PhD (416-573-9047, natalie.ein@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PHQ-9 - Patient Health Questionnaire 9 (time frame: 5 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.