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?

The goal of this prospective, randomized clinical trial is to learn whether pharmacogenomic (PGx)-guided comprehensive medication management delivered by pharmacists in community pharmacies will improve antidepressant treatment outcomes.

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

Participants 18 years of age or older who have undergone PGx testing (e.g. through an independent biobanking study (Pitt+Me Discovery) who require initiation or adjustment of antidepressant therapy will be randomly assigned to receive either PGx-guided comprehensive medication management or usual care. Those who receive usual care will receive their PGx results at the end of the study. Researchers will compare the groups to assess whether PGx-guided care provided in partnership with community pharmacists and prescribers results in better depression and medication outcomes.

Who Is on the Research Team?

PE

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+