Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335043
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-13
Brief Title:
Personalized Pharmacotherapy Using Pharmacogenetics in Veterans
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
Personalized Pharmacotherapy Using Pharmacogenetics in Veterans Seeking Treatment for Mental Health
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PGx
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 Josephs 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 participants treatment planning and changes to treatment planning Where applicable past treatment data from patient participants acquired at the St Josephs 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 Josephs OSI Clinic will act as a standard care comparator treatment group Patient participants 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None