Pharmacogenomic-Guided Medication Management for Depression

(COMPASS-PGx Trial)

PE
LP
Overseen ByLinda Prebehalla, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Pittsburgh
Must be taking: SSRIs, SNRIs, Bupropion
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether genetic information can help pharmacists manage antidepressant medications more effectively. It focuses on individuals who have recently started or changed their antidepressant prescription and have mild depressive symptoms. Participants will either receive personalized medication management based on their genetic test results (comprehensive medication management with pharmacogenomic results) or follow the usual care routine. The goal is to determine if this personalized approach leads to better outcomes in managing depression. This trial may suit English-speaking individuals who are patients at specific pharmacies and have agreed to participate in a biobanking research study. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance personalized medicine for depression.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. It focuses on managing antidepressant treatment, so you might need to adjust your antidepressant medication, but it's best to discuss this with the trial team.

What prior data suggests that pharmacogenomic-guided medication management is safe for depression treatment?

Research has shown that pharmacogenomic (PGx) testing, which examines how genes affect a person's reaction to medications, can safely guide depression treatment. One study found that patients using medications chosen with PGx testing were 41% to 78% more likely to experience symptom relief and 20% to 49% more likely to respond well to treatment. This suggests that using PGx testing to select medications can be both effective and safe.

Another study indicated that PGx-guided treatment can improve symptom relief and response rates in depression without major safety concerns. The treatment was generally well-tolerated, with no significant side effects reported.

Overall, PGx testing in managing depression treatments has been shown to be safe and may help improve outcomes for patients.12345

Why are researchers excited about this trial?

Researchers are excited about using pharmacogenomic-guided medication management for depression because it personalizes treatment by using a patient's genetic information to tailor medication choices. Unlike the standard trial-and-error approach with antidepressants like SSRIs or SNRIs, this method aims to improve effectiveness and reduce side effects by identifying the best-suited medications from the start. This innovative approach could lead to faster relief from symptoms and a more efficient path to finding the right treatment for each individual.

What evidence suggests that comprehensive medication management with pharmacogenomic results is effective for depression?

Research shows that using gene testing to guide antidepressant treatment can improve outcomes for people with depression. In this trial, participants in the experimental arm will receive comprehensive medication management with pharmacogenomic (PGx) testing results. Some studies have found that patients who underwent this testing experienced improvements in managing their depression. Specifically, gene testing can increase the chances of remission, meaning symptoms of depression can greatly decrease or disappear. Several studies have demonstrated that gene testing enhances treatment effectiveness, yielding clear positive results. This testing proves especially useful for treating major depressive disorder, where finding the right medication can be challenging.36789

Who Is on the Research Team?

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Philip E Empey, PharmD, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adults over 18 with depression who are starting or changing doses of certain antidepressants (SSRIs or SNRIs/bupropion). They must have mild depressive symptoms confirmed by a PHQ8 assessment, speak English, and be part of the Pitt+Me Discovery biobanking study. Participants need to be UPMC patients or willing to become one.

Inclusion Criteria

I have mild or more severe depression symptoms.
I am starting or changing my dose of certain depression medications.
I am or can become a UPMC patient and have or can get a UPMC provider.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PGx-guided comprehensive medication management or usual care

6 months
Regular visits with community pharmacists

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Follow-up assessments at 6 weeks, 12 weeks, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Comprehensive Medication Management with Pharmacogenomic Results

Trial Overview

The trial is testing if pharmacist-led medication management using pharmacogenomic (PGx) test results can improve depression treatment outcomes compared to usual care without PGx guidance. Patients will either receive personalized medication adjustments based on their genetic profile or standard treatment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Usual careExperimental Treatment1 Intervention
Group II: Comprehensive medication management with PGx testing resultsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

Pennsylvania Department of Health

Collaborator

Trials
42
Recruited
999,000+

Citations

Pharmacogenomic Testing in Depression: A 2021 Update

In patients with depression, some studies showed that there were improvements in the clinical effectiveness outcomes in those who received gene testing and ...

Evaluating treatment outcomes in pharmacogenomic ...

Our results suggest that use of PGx to guide antidepressant treatment could increase the rate of remission in adults with moderate to severe depression, whereby ...

Effect of Pharmacogenomic Testing for Drug-Gene ...

Pharmacogenomic testing may be particularly helpful in the treatment of major depressive disorder (MDD) where initial treatment response can be ...

Pharmacogenomic Clinical Support Tools for the Treatment ...

Three trials (27%) demonstrated efficacy on the primary outcome measure with statistical significance; the three studies used different PGx ...

An Evaluation of the Impact of Pharmacist Comprehensive ...

The primary aim is to determine whether comprehensive medication management with review of PGx testing results improves depression symptoms, ...

Efficacy and safety of pharmacogenomic-guided ... - PMC

Patients who received PGx-guided medications were 41% to 78% more likely to achieve remission and 20% to 49% more likely to respond to ...

Effect of pharmacogenomic testing on the clinical treatment ...

Pharmacogenomic testing is available to guide the treatment of depression. Pharmacogenomic guided medication enhances remission and response rates.

Pharmacogenomics for Improved Outcomes and ...

Outcomes also showed that nearly 38% received a prescription for a new level-A drug; nearly 25% of these patients were prescribed 2 level-A ...

Pharmacogenomic Testing in Depression Treatment ...

The goal of this activity is for learners to be better able to examine the scientific ratio- nale for pharmacogenetic (PGx) testing in.