PharmacogeneticsCOMPASS-PGxNCT07373470
An Evaluation of the Impact of Pharmacist Comprehensive Medication Management With Pharmacogenomic Results to Improve Depression Outcomes in Community Pharmacies.
A study testing Comprehensive medication management with PGx testing results in people with Pharmacogenetics and Depression - Major Depressive Disorder, run by University of Pittsburgh at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharmacogenetics, Depression - Major Depressive Disorder, Pharmacogenomic Drug Interaction
- What is being tested?
- Comprehensive medication management with PGx testing results
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2026to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Philip E Empey, PharmD, PhD, (412) 648-7219, CompassPGx@pitt.edu
Rhianna Ericson, MPH, (412) 624-8679, CompassPGxx@pitt.edu
About this study
Official title: Genotype-guided Comprehensive Medication Management to Improve Depression Outcomes in Pennsylvania
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.
- Conditions
- Pharmacogenetics, Depression - Major Depressive Disorder, Pharmacogenomic Drug Interaction, Community Pharmacy Services
- Being tested
- Comprehensive medication management with PGx testing results, Usual Care
- Keywords
- precision medicine, pharmacogenomics, PGx, Comprehensive medication management, pharmacist, community pharmacy, medication review, antidepressants, pharmacogenomic testing, management of depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive medication management with PGx testing resultsOther
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.
Usual CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive medication management with PGx testing results | Experimental | Participants will have a study visit with a community pharmacist for comprehensive medication management with review of PGx testing results. Receives: Other: Comprehensive medication management with PGx testing results |
| Usual care | Other | 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire (PHQ-8) score
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).
Measured: Baseline, 6 Weeks, 12 Weeks, 6 Months
Secondary outcomes (8)
Change in the Extent of Adherence and Reasons for Nonadherence Survey (Voils et al.) score
The Extent of Adherence and Reasons for Nonadherence Survey (Voils et al.) is a validated self-report measure assessing medication adherence over the past 7 days. It is scored on a 1-5 Likert scale and averaged to produce a continuous score, with higher scores indicating better adherence. The Reasons for Nonadherence scale assesses specific barriers to taking medication as prescribed, with items rated on a 1-5 scale and assessed individually to identify the degree to which each barrier contributed to missed doses.
Measured: Baseline, 6 Months
Change in Generalized Anxiety Disorder Assessment (GAD-7) score
The Generalized Anxiety Disorder Assessment (GAD-7) is a 7-item self-report measure assessing anxiety symptoms over the past two weeks, with items scored 0-3 for a total score of 0-21; higher scores indicate more severe anxiety, categorized as minimal (0-4), mild (5-9), moderate (10-14), and severe (15-21).
Measured: Baseline, 6 Weeks, 12 Weeks, 6 Months
Proportion of pharmacist recommendations were accepted
Proportion of pharmacist recommendations to address medication-related problems that were accepted by providers as assessed by EHR and fill data review.
Measured: 6 months
Change in frequency of CPIC/FDA guideline concordant prescribing
Change in frequency of concordance of participant medication regimen with pharmacogenomics prescribing recommendations according to the Clinical Pharmacogenomics Implementation Consortium (CPIC) and U.S. Food \& Drug Administration (FDA) guidelines using electronic health record data.
Measured: Baseline, 6 Months
Number of adverse events as assessed using the Frequency, Intensity, and Burden of Side Effect rating scale (FIBSER).
The Frequency, Intensity, and Burden of Side Effect Rating Scale (FIBSER) is a 3-item self-report measure assessing medication side effects. It evaluates the frequency, intensity, and functional burden of side effects over the past week, with each item rated on a 0-6 scale; higher scores indicate more frequent, severe, or burdensome side effects. Clinically, a total score of 0-2 typically requires no change in treatment, 3-4 side effects may warrant targeted management, and 5-6 indicates that treatment modification should be considered to improve tolerability and adherence.
Measured: Baseline, 6 Weeks, 12 Weeks, 6 Months
Frequency of Actionable Genotypes
Frequency of actionable genotypes (in the entire study population) based on report of a genotype-predicted phenotype. Actionable genotypes are defined as those with recommendations for a change in prescribing by a CPIC (Clinical Pharmacogenetics Implementation Consortium) guidelines or FDA recommendations.
Measured: 6 months
Number of participant medications with PGx guidance based on PGx testing results.
This measure counts the number of a participant's medications for which pharmacogenomic (PGx) guidance is available based on PGx testing results. Medications with PGx guidance may have dosing recommendations, alternative drug options, or monitoring considerations informed by the participant's genetic profile.
Measured: 6 months
Change in healthcare utilization
Change in participant ER visits, hospitalizations, urgent care visits, specialist appointments, primary care appointments, and unplanned care using UPMC EHR data.
Measured: From Baseline to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start9 Sep 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacogeneticsStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Responsible party
- Principal investigator, Philip Empey, University of Pittsburgh
- Investigators
- Philip E Empey, PharmD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373470
- Sponsor's protocol ID
- STUDY21120100
- Acronym
- COMPASS-PGx
- Status last verified
- Sep 2026
- First submitted
- 12 Jan 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No