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Набор скоро начнётся NCT07373470

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

Без фазы С лечением Pharmacogenetics Depression - Major Depressive Disorder Pharmacogenomic Drug Interaction Community Pharmacy Services

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Comprehensive medication management with PGx testing results, Usual Care.
Кому может быть актуально
Состояния в реестре: Pharmacogenetics, Depression - Major Depressive Disorder, Pharmacogenomic Drug Interaction, Community Pharmacy Services. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Другое 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.
  • Другое 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.

Первичные конечные точки

  • Change in Patient Health Questionnaire (PHQ-8) score [Срок оценки: Baseline, 6 Weeks, 12 Weeks, 6 Months]
Вторичные конечные точки (8)
  • Change in the Extent of Adherence and Reasons for Nonadherence Survey (Voils et al.) score [Срок оценки: Baseline, 6 Months]
  • Change in Generalized Anxiety Disorder Assessment (GAD-7) score [Срок оценки: Baseline, 6 Weeks, 12 Weeks, 6 Months]
  • Proportion of pharmacist recommendations were accepted [Срок оценки: 6 months]
  • Change in frequency of CPIC/FDA guideline concordant prescribing [Срок оценки: Baseline, 6 Months]
  • Number of adverse events as assessed using the Frequency, Intensity, and Burden of Side Effect rating scale (FIBSER). [Срок оценки: Baseline, 6 Weeks, 12 Weeks, 6 Months]
  • Frequency of Actionable Genotypes [Срок оценки: 6 months]
  • Number of participant medications with PGx guidance based on PGx testing results. [Срок оценки: 6 months]
  • Change in healthcare utilization [Срок оценки: From Baseline to 6 Months]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

США · 1 центр
  • University of Pittsburgh — Pittsburgh

Идентификаторы

NCT: NCT07373470 · STUDY21120100

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗