The Efficacy of Trazodone for the Treatment of Insomnia in Older Adults: A Randomized Controlled Trial (The TRADITION Study)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Insomnia severity index
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 65 or older in an outpatient setting
- •Insomnia according to the criteria of the ICSD-3R
排除标准
- •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
- •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.
研究组 & 干预措施
Crossover Trazodone then Placebo arm
Participants will receive 25 to 50 mg of trazodone once daily at bedtime for 28 days. After a 14-day washout period, participants will receive a placebo for another 28 days.
干预措施: Trazodone 25 mg (Drug)
Crossover Placebo then Trazodone arm
Participants will receive a placebo once daily at bedtime for 28 days. After a 14-day washout period, participants will receive 25 to 50 mg of trazodone for another 28 days.
干预措施: Trazodone 25 mg (Drug)
结局指标
主要结局
Insomnia severity index
时间窗: At baseline or at day 1, at day 36 and at day 77.
The ISI is a self-assessment questionnaire that evaluates the nature, severity, and impact of insomnia. The typical recall period is the past month. The dimensions assessed are: the severity of falling asleep, maintaining sleep, and waking up too early in the morning; sleep dissatisfaction; the interference of sleep difficulties with daytime functioning; the visibility of sleep problems to others; and the distress caused by sleep difficulties. A 5-point Likert scale is used to evaluate each item. The total score is interpreted as follows: no insomnia 0-7; subclinical insomnia 8-14; moderate insomnia 15-21; and severe insomnia 22-28. It is increasingly used as a measure of treatment response in clinical research. Data confirm its reliability and the validity of the measurements obtained in the older adult population.
次要结局
- Insomnia daytime symptoms and Impacts Questionnaire(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(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(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(At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment)
- Subjective sleep efficiency(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(At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment)
- Adverse events(At Day 36 and day 77)
- Objective Wake After Sleep Onset(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(At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment)
- Objective Sleep Efficiency(At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment)