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

NCT07373470

Not Yet RecruitingNA

Sponsor: University of Pittsburgh

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

Interventions: Comprehensive medication management with PGx testing results, Usual Care

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Pittsburgh, Pennsylvania, United States