An Evaluation of the Impact of Pharmacist Comprehensive Medication Management With Pharmacogenomic Results to Improve Depression Outcomes in Community Pharmacies.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Comprehensive medication management with PGx testing results, Usual Care.
- Who it may be relevant to
- Registry conditions: Pharmacogenetics, Depression - Major Depressive Disorder, Pharmacogenomic Drug Interaction, Community Pharmacy Services. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Genotype-guided Comprehensive Medication Management to Improve Depression Outcomes in Pennsylvania
Overview
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.
Interventions
- 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.
Primary outcome measures
- Change in Patient Health Questionnaire (PHQ-8) score [Time frame: Baseline, 6 Weeks, 12 Weeks, 6 Months]
Secondary outcome measures (8)
- Change in the Extent of Adherence and Reasons for Nonadherence Survey (Voils et al.) score [Time frame: Baseline, 6 Months]
- Change in Generalized Anxiety Disorder Assessment (GAD-7) score [Time frame: Baseline, 6 Weeks, 12 Weeks, 6 Months]
- Proportion of pharmacist recommendations were accepted [Time frame: 6 months]
- Change in frequency of CPIC/FDA guideline concordant prescribing [Time frame: Baseline, 6 Months]
- Number of adverse events as assessed using the Frequency, Intensity, and Burden of Side Effect rating scale (FIBSER). [Time frame: Baseline, 6 Weeks, 12 Weeks, 6 Months]
- Frequency of Actionable Genotypes [Time frame: 6 months]
- Number of participant medications with PGx guidance based on PGx testing results. [Time frame: 6 months]
- Change in healthcare utilization [Time frame: From Baseline to 6 Months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- University of Pittsburgh — Pittsburgh
Identifiers
NCT: NCT07373470 · STUDY21120100