Clinical trial NCT06335043: Personalized Pharmacotherapy Using Pharmacogenetics in Veterans
Official title: Personalized Pharmacotherapy Using Pharmacogenetics in Veterans Seeking Treatment for Mental Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pharmacogenetic Testing to Determine Pharmacological Treatment in PTSD
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: PHQ-9 - Patient Health Questionnaire 9
timeFrame: 5 minutes
measure: GAD-7 - General Anxiety Disorder-7
timeFrame: 5 minutes
measure: PCL-5 - Posttraumatic Stress Disorder Checklist - 5
timeFrame: 5 minutes
measure: OQ-45 - Outcome Questionnaire 45
timeFrame: 10 minutes
measure: Pharmacological Side Effect Measure
timeFrame: 10 minutes
measure: Electronic Medical Record Extraction Measure
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: MacDonald Franklin OSI Research and Innovation Centre
state: Ontario
Study officials:
References: