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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT07373470
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PittsburghPittsburghPennsylvania15260
Philip E Empey, PharmD, PhD
[email protected]
(412) 648-7219
Rhianna Ericson, MPH
[email protected]
(412) 624-8679
Mylynda Massart, MD, PhD (SUB_INVESTIGATOR)
Kim Coley, PharmD (SUB_INVESTIGATOR)
Lucas Berenbrok, PharmD, MS (SUB_INVESTIGATOR)

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By research site
University of Pittsburgh· Pittsburgh, PA

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