Personalized Pharmacotherapy Using Pharmacogenetics in Veterans

NCT ID: NCT06335043

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-25
• Study Completion Date: 2027-04-25

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 Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mental Health Provider

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Pharmacogenetics Testing

Intervention Type: GENETIC

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

Patient without Pharmacogenetic Testing

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pharmacogenetics Testing

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

Intervention Type: GENETIC

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;
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Don Richardson

Scientific Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

MacDonald Franklin OSI Research and Innovation Centre

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Natalie Ein, PhD

Role: CONTACT

natalie.ein@sjhc.london.on.ca

416-573-9047

Facility Contacts

Natalie Ein, PhD

Role: primary

natalie.ein@sjhc.london.on.ca

416-573-9047

Other Identifiers

119245

Identifier Type: -

Identifier Source: org_study_id