Genetic Testing for Mental Health

(PGx Trial)

Overseen By Natalie Ein, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lawson Health Research Institute

Disqualifiers: Unable to provide informed consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

155 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how genetic testing can aid in selecting mental health treatments for veterans and RCMP members. It examines whether genetic information can enhance treatment for conditions such as PTSD, depression, and anxiety. Participants may choose genetic testing (pharmacogenetics testing) or continue with standard care, and the results will be compared. This trial suits veterans or RCMP members receiving treatment at St. Joseph's OSI Clinic with a current diagnosis of an operational stress injury (OSI). As an unphased trial, it offers participants the chance to contribute to innovative research that could personalize and improve mental health treatments.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current treatment, as the study is observational and focuses on genetic testing for mental health.

What prior data suggests that pharmacogenetic testing is safe for mental health treatment?

Research has shown that pharmacogenetic testing can tailor mental health treatments to a person's unique genetic makeup. This approach often leads to better treatment outcomes and reduces the risk of unwanted side effects. For example, studies indicate that this testing can identify genetic factors that might cause adverse reactions to certain drugs. With this information, doctors can select safer medications for patients.

The testing is generally straightforward, involving a sample like a cheek swab or a blood sample to determine a person’s genetic profile. It is non-invasive and has no direct side effects. The primary advantage is its ability to minimize the risk of side effects from medications that may not suit someone's genetic makeup.

In summary, pharmacogenetic testing offers a promising method to enhance the safety and effectiveness of mental health treatments by personalizing medication choices based on genetic information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about pharmacogenetic testing for mental health because it personalizes treatment plans based on an individual's genetic makeup. Unlike traditional treatments that often involve trial-and-error with medications like SSRIs or SNRIs, pharmacogenetic testing aims to predict how a patient will respond to a particular medication, potentially reducing the time it takes to find the right treatment. This approach could lead to more effective and quicker solutions for managing mental health conditions, minimizing side effects, and improving overall patient outcomes.

What evidence suggests that pharmacogenetic testing is effective for mental health treatment?

Research has shown that pharmacogenetic testing (PGx) can enhance treatment effectiveness for mental health issues. In this trial, some participants will opt-in for PGx testing, which matches medications to an individual's genetic profile, potentially reducing the need to change or stop medications early. A study that combined results from several trials found that people using PGx-guided therapy responded better to treatment and experienced fewer symptoms. Experts from the Mayo Clinic have observed that PGx testing can lead to improved outcomes for patients with mental health conditions. Meanwhile, other participants in this trial will not receive PGx testing, allowing for a comparison of treatment outcomes. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for current patients at the London St. Joseph's OSI Clinic who are Veterans or RCMP members, at least 18 years old, with a diagnosis of an Operational Stress Injury (OSI) and have never received pharmacogenetic testing. Psychiatrists working there with active caseloads can also participate.

Inclusion Criteria

Patient participant: Are a current patient at the London St. Joseph's OSI Clinic

Patient participant: Current diagnosis of an OSI

Patient participant: Consents to the use of CROMIS data for the purpose of this study

Exclusion Criteria

I am able to and have provided informed consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants opt-in to pharmacogenetic testing or continue with standard pharmacologic care

24 weeks

Regular visits as per standard care protocol

Follow-up

Participants are monitored for PTSD, depression, anxiety severity, and medication-related side effects until discharge or after 24 weeks

24 weeks

Virtual exit interview at the end of participation

What Are the Treatments Tested in This Trial?

Interventions

• Pharmacogenetics Testing

Trial Overview The study observes how genetic testing (pharmacogenetics) influences mental health treatment in veterans and their attitudes towards it. It compares outcomes between those opting for PGx-guided treatment and those receiving standard care without genetic testing.

How Is the Trial Designed?

Group I: Patient with Pharmacogenetic Testing Experimental Treatment 1 Intervention

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 II: Patient without Pharmacogenetic Testing Active Control 1 Intervention

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

Group III: Mental Health Provider Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

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

Lead Sponsor

Trials

686

Recruited

427,000+

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

Lead Sponsor

Trials

678

Recruited

421,000+

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

Lead Sponsor

Trials

668

Recruited

424,000+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK595332/

An Overview of Pharmacogenomic Testing for Psychiatric ... The results of the meta-analysis suggested that people who received therapy guided by pharmacogenomic testing experienced improved response rates and remission ...

2. accpjournals.onlinelibrary.wiley.com accpjournals.onlinelibrary.wiley.com/doi/10.1002/jac5.1892

Pharmacogenomics to support mental health medication ... A promising approach to reduce early medication discontinuation or switching is through the strategic application of pharmacogenomics (PGx).

3. ajmc.com ajmc.com/view/need-for-pharmacogenomic-testing-in-mental-health-care-explored-at-amcp-2024

Need for Pharmacogenomic Testing in Mental Health Care ... Presenters from Mayo Clinic discussed the benefits of implementing pharmacogenomic testing in mental health care for the betterment of patient outcomes.

4. genesight.com genesight.com/

GeneSight May Help Gain Mental Health Meds Insights GeneSight Psychotropic is a pharmacogenomic test which means that it analyzes how your genes may affect medication outcomes.

5. digitalcommons.fiu.edu digitalcommons.fiu.edu/cgi/viewcontent.cgi?article=1263&context=cnhs-studentprojects

Assessing Utilization and Outcomes of Pharmacogenomic ... This study aims to evaluate the clinical outcomes of PGx testing in a pediatric population at an outpatient mental health practice in. Miami ...

6. med.uth.edu med.uth.edu/psychiatry/pharmacogenetics-test/

Pharmacogenetics Test - McGovern Medical School Pharmacogenetic testing helps identify genetic factors associated with an increased risk of ADRs, enabling clinicians to make informed decisions about drug ...

7. fda.gov fda.gov/medical-devices/precision-medicine/table-pharmacogenetic-associations

Table of Pharmacogenetic Associations Pharmacogenetic tests, along with other information about patients and their disease or condition, can play an important role in drug therapy.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11186746/

Pharmacogenetic testing in primary care could bolster ... Pharmacogenetic testing could reduce the time to identify a safe and effective medication for depression; however, it is underutilized in practice.