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

Genotype-guided Comprehensive Medication Management to Improve Depression Outcomes in Pennsylvania

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether pharmacists can use gene test results to help choose and manage depression medicines and improve symptoms, compared with usual care. It is for adults age 18 or older who have had this testing and need to start or change depression medicine.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and have had gene testing that may help guide medicine choices.
  • Use a selected community pharmacy for a new prescription or a change in dose or schedule for citalopram, escitalopram, sertraline, or paroxetine. These are depression medicines called SSRIs.
  • Or, take one of those SSRIs and have a new prescription or change in desvenlafaxine, duloxetine, venlafaxine, or bupropion.
  • Have depression symptoms confirmed by a PHQ8 questionnaire score above 5.
  • Be a UPMC patient with a UPMC provider, or be willing and able to become a patient and get a provider there.
  • Have signed a consent form to join the Pitt+Me Discovery study, which collects samples for research.
  • Speak English.

Who can't join

  • Cannot receive full medicine management from the selected pharmacy or pharmacist.
  • Report having schizophrenia, a mental illness that can affect thoughts and what seems real.
  • Report having an untreated sleep disorder.
  • Are in Pitt+Me Discovery but chose not to receive test results, or have already received them.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

PA