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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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: 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.
  • 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.

Recruiting Locations

University of Pittsburgh
Pittsburgh, Pennsylvania 15260
Contact:
Philip E Empey, PharmD, PhD
(412) 648-7219
CompassPGx@pitt.edu

More Details

Status
Recruiting
Sponsor
University of Pittsburgh

Study Contact

Linda Prebehalla, RN
(412) 624-8129
CompassPGx@pitt.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.