NCT07373470 · University of Pittsburgh
An Evaluation of the Impact of Pharmacist Comprehensive Medication Management With Pharmacogenomic Results to Improve Depression Outcomes in Community Pharmacies.
(COMPASS-PGx)
What this study is about
The goal of this forward-looking, randomly assigned clinical trial is to learn whether pharmacogenomic (PGx)-guided comprehensive medication management delivered by pharmacists in community pharmacies will improve antidepressant treatment outcomes.
View original scientific description
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.
Interventions
OTHER
Comprehensive medication management with PGx testing results
A comprehensive medication management with PGx testing includes a pharmacist-provided review of health history, past/current medications, and assessment of potential medication related problems. A review of PGx testing results will be integrated to identify any PGx-related medication issues. Recommendations will then be made to study participants' providers (regular care team) for any decisions regarding potential therapy changes.
OTHER
Usual Care
Participants will receive no study intervention (usual care) and will have a comprehensive medication management with review of PGx testing results at the end of the study.
Primary outcome measures
Change in Patient Health Questionnaire (PHQ-8) score
Time frame: Baseline, 6 Weeks, 12 Weeks, 6 Months
The Patient Health Questionnaire-8 (PHQ-8) is an 8-item self-report measure assessing depressive symptoms. Each item is scored from 0-3, producing a total score of 0-24, with higher scores indicating more severe depressive symptoms. Standard severity categories are minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-24).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- At targeted community pharmacy for:
- New prescription or change in dose/schedule of SSRI (citalopram, escitalopram, sertraline, paroxetine), OR
- Concurrent SSRI (citalopram, escitalopram, sertraline, paroxetine) and new prescription/change in SNRI (desvenlafaxine, duloxetine, and venlafaxine) / bupropion.
- Depressive symptoms confirmed by PHQ8 assessment (\>5 indicating at least mild depressive symptoms)
- UPMC patient (or able/willing to become one) and has UPMC provider (or able/willing to obtain one)
- Signed consent to join Pitt+Me Discovery biobanking research study.
- English-speaking
Exclusion criteria
- Inability to receive CMM at specific pharmacy/pharmacist
- Comorbid diagnosis of schizophrenia (patient-reported)
- Untreated sleep disorder (patient-reported)
- Pitt+Me Discovery participant who has elected to not receive return of results, or who has already received results previously
Where
- Pittsburgh, Pennsylvania
Collaborators
Pennsylvania Department of Health
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 14, 2026 · Source of record for eligibility and locations