Trazodone 25 mg: Trazodone 25 mg at bedtime, which can be increased to 50 mg after 14 days of treatment.
Study summary
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.
Eligibility
Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Individuals aged 65 or older in an outpatient setting
* Insomnia according to the criteria of the ICSD-3R
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Insomnia severity index — 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.
Trial sites (1)
Facility
City
Region
Status
Centre Hospitalier de l'Université de Montréal
Montreal
Quebec
Recruiting
More Centre hospitalier de l'Université de Montréal (CHUM) trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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