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Recruiting NCT06335043

Personalized Pharmacotherapy Using Pharmacogenetics in Veterans

No phase Interventional Pharmacogenetic Testing to Determine Pharmacological Treatment in PTSD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pharmacogenetics Testing.
Who it may be relevant to
Registry conditions: Pharmacogenetic Testing to Determine Pharmacological Treatment in PTSD. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Personalized Pharmacotherapy Using Pharmacogenetics in Veterans Seeking Treatment for Mental Health

Overview

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.

Interventions

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

Primary outcome measures

  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • MacDonald Franklin OSI Research and Innovation Centre — London

Identifiers

NCT: NCT06335043 · 119245

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗