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

ClinicalTrials.gov IDNCT07373470

PhaseNA

Enrollment220

SponsorUniversity of Pittsburgh

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Pharmacogenetics, Depression - Major Depressive Disorder, Pharmacogenomic Drug Interaction, Community Pharmacy Services

About this study

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 outcomes

Change in Patient Health Questionnaire (PHQ-8) score (Baseline, 6 Weeks, 12 Weeks, 6 Months)

Eligibility information

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 locations

University of Pittsburgh, Pittsburgh, Pennsylvania 15260 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.