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Идёт набор NCT06983080

Efficacy of Trazodone to Treat Insomnia in Older Adults (TRADITION Study)

Фаза II С лечением Insomnia Chronic Older People Drug Therapy

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: Trazodone 25 mg.
Кому может быть актуально
Состояния в реестре: Insomnia Chronic, Older People, Drug Therapy. Базовые параметры: от 65 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
Канада
Следующий шаг
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Официальное название

The Efficacy of Trazodone for the Treatment of Insomnia in Older Adults: A Randomized Controlled Trial (The TRADITION Study)

Обзор

This study aims to evaluate how effective trazodone is in treating insomnia in adults aged 65 years and older. The main question it aims to answer is : \- Is trazodone more effective than a placebo in reducing the severity of insomnia symptoms in older adults? Participants will : * Take 25 to 50 mg of trazodone or a matching placebo before bed for 28 days. After a 2-week break, they will then take the other medication for another 28 days. * Visit the clinic three times for checkup and test * Complete a sleep diary and wear an actimeter during the night.

Вмешательства

  • Препарат Trazodone 25 mg
    Trazodone 25 mg at bedtime, which can be increased to 50 mg after 14 days of treatment.

Первичные конечные точки

  • Insomnia severity index [Срок оценки: At baseline or at day 1, at day 36 and at day 77.]
Вторичные конечные точки (10)
  • Insomnia daytime symptoms and Impacts Questionnaire [Срок оценки: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment]
  • Subjective Sleep onset latency [Срок оценки: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment]
  • Subjective wake after sleep onset [Срок оценки: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment]
  • Subjective Total sleep time [Срок оценки: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment]
  • Subjective sleep efficiency [Срок оценки: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment]
  • Objective sleep onset latency [Срок оценки: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment]
  • Objective Wake After Sleep Onset [Срок оценки: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment]
  • Objective Total Sleep Time [Срок оценки: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment]
  • Objective Sleep Efficiency [Срок оценки: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment]
  • Adverse events [Срок оценки: At Day 36 and day 77]

Критерии участия

Критерии включения

  • Individuals aged 65 or older in an outpatient setting
  • Insomnia according to the criteria of the ICSD-3R

Критерии исключения

  • Contraindication to trazodone (hypersensitivity)
  • Presence of a ventricular cardiac arrhythmia (e.g., torsades de pointes)
  • Recent myocardial infarction (< 6 months)
  • Substances that may alter sleep (hypnotics or any other medication intended to induce sleep, such as mirtazapine or quetiapine, corticosteroids, melatonin, psychostimulant drugs)
  • Active, unstable psychiatric disorder
  • Initiation or titration of an antidepressant within the past 6 months
  • Cognitive-behavioral therapy ongoing or planned during the study period
  • Major neurocognitive disorder (NCD) moderate or severe, or other cognitive disorders that may prevent the participant from being able to participate in the study, according to the judgment of the evaluating physician
  • Parkinson's disease
  • Priapism
  • Known angle-closure glaucoma
  • Symptomatic restless leg syndrome > 3 times per week
  • QTc interval > 500 ms
  • Parasomnias, dyssomnias other than insomnia
  • Severe sleep apnea with AHI > 30 without CPAP treatment
  • Use of a monoamine oxidase inhibitor
  • Use of a strong CYP 3A4 inducer or inhibitor
  • Hospitalized individuals
  • Seizure within the past 6 months
  • History of orthostatic hypotension
  • History of delirium within the last 6 months
  • Consumption of > 14 alcoholic drinks per day or use of alcohol to induce sleep.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Канада · 1 центр
  • Centre Hospitalier de l'Université de Montréal — Montreal

Идентификаторы

NCT: NCT06983080 · 2025-12893

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗