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.
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)
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
University of Pittsburgh
Lead sponsor
Pennsylvania Department of Health
Collaborator