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

University of Pittsburgh

Status: Not yet enrolling

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

Treatments: Other: Comprehensive medication management with PGx testing results; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07373470

STUDY21120100

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Comprehensive medication management with PGx testing results

Experimental group

Description:

Participants will have a study visit with a community pharmacist for comprehensive medication management with review of PGx testing results.

Treatment:

Other: Comprehensive medication management with PGx testing results

Usual care

Other group

Description:

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.

Treatment:

Other: Usual Care