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

NCT07373470 | Not Yet Recruiting

• 1 other identifier: STUDY21120100
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  Baseline, 6 Months

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

  Baseline, 6 Weeks, 12 Weeks, 6 Months

• Proportion of pharmacist recommendations were accepted

  6 months

• Change in frequency of CPIC/FDA guideline concordant prescribing

  Baseline, 6 Months

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

  Baseline, 6 Weeks, 12 Weeks, 6 Months

Other Outcomes (1)

• Community pharmacists' needs for expert support in deploying PGx

  6 Months

Study Arms (2)

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.

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.

Other: Usual Care

Interventions

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.

Usual care

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.

Comprehensive medication management with PGx testing results

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Pennsylvania Department of Health: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Study Officials

• Philip E Empey, PharmD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Prebehalla, RN

CONTACT

(412) 624-8129; CompassPGx@pitt.edu

Philip E Empey, PharmD, PhD

CONTACT

(412) 624-7219; compasspgx@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 28, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)