Recruiting

PGx-Guided Care

Sponsor:

University of Pittsburgh

Code:

NCT07373470

Conditions

Pharmacogenetics

Depression - Major Depressive Disorder

Pharmacogenomic Drug Interaction

Community Pharmacy Services

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Comprehensive medication management with PGx testing results

Usual Care

Study Details

Brief 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.

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

Study ID

NCT07373470

Start date

Sep, 2026

Status verified date

Sep, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Comprehensive medication management with PGx testing results

Participants will have a study visit with a community pharmacist for comprehensive medication management with review of PGx testing results.

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.

Interventions

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.

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 measure

  • Change in Patient Health Questionnaire (PHQ-8) score [ Time Frame: Baseline, 6 Weeks, 12 Weeks, 6 Months ]

Central Contacts and Locations

Central contacts

Linda Prebehalla, RN

(412) 624-8129CompassPGx@pitt.edu

Philip E Empey, PharmD, PhD

(412) 624-7219compasspgx@pitt.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15260

Contacts

Philip E Empey, PharmD, PhD

(412) 648-7219CompassPGx@pitt.edu

Rhianna Ericson, MPH

(412) 624-8679CompassPGxx@pitt.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • precision medicine
  • pharmacogenomics
  • PGx
  • Comprehensive medication management
  • pharmacist
  • community pharmacy
  • medication review
  • antidepressants
  • pharmacogenomic testing
  • management of depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-09-03.