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NCT Number: NCT07373470

An Evaluation of the Impact of Pharmacist Comprehensive Medication Management With Pharmacogenomic Results to Improve Depression Outcomes in Community Pharmacies.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location contact

Kim Coley, PharmD

SUB_INVESTIGATOR

Lucas Berenbrok, PharmD, MS

SUB_INVESTIGATOR

Mylynda Massart, MD, PhD

SUB_INVESTIGATOR

Philip E Empey, PharmD, PhD

CONTACT

[email protected]

(412) 648-7219

Rhianna Ericson, MPH

CONTACT

[email protected]

(412) 624-8679

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comprehensive medication management with PGx testing results

Other

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 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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Change in the Extent of Adherence and Reasons for Nonadherence Survey (Voils et al.) score

    Time frame: Baseline, 6 Months

    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.

  2. Change in Generalized Anxiety Disorder Assessment (GAD-7) score

    Time frame: Baseline, 6 Weeks, 12 Weeks, 6 Months

    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).

  3. Proportion of pharmacist recommendations were accepted

    Time frame: 6 months

    Proportion of pharmacist recommendations to address medication-related problems that were accepted by providers as assessed by EHR and fill data review.

  4. Change in frequency of CPIC/FDA guideline concordant prescribing

    Time frame: Baseline, 6 Months

    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.

  5. Number of adverse events as assessed using the Frequency, Intensity, and Burden of Side Effect rating scale (FIBSER).

    Time frame: Baseline, 6 Weeks, 12 Weeks, 6 Months

    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.

  6. Frequency of Actionable Genotypes

    Time frame: 6 months

    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.

  7. Number of participant medications with PGx guidance based on PGx testing results.

    Time frame: 6 months

    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.

  8. Change in healthcare utilization

    Time frame: From Baseline to 6 Months

    Change in participant ER visits, hospitalizations, urgent care visits, specialist appointments, primary care appointments, and unplanned care using UPMC EHR data.

Other outcomes

  1. Community pharmacists' needs for expert support in deploying PGx

    Time frame: 6 Months

    Community pharmacists' needs for expert support in deploying PGx Number and types of questions asked by community pharmacists to PGx experts on study team through the duration of the study.

Study contacts

Contact information is provided by the study sponsor or research team.

Linda Prebehalla, RN

CONTACT

[email protected]

(412) 624-8129

Philip E Empey, PharmD, PhD

CONTACT

[email protected]

(412) 624-7219

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Pennsylvania Department of Health

Registry information

Official study title

Genotype-guided Comprehensive Medication Management to Improve Depression Outcomes in Pennsylvania

Acronym: COMPASS-PGx

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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