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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

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

🚫 You may not be able to join if…

• 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

+ 2 more criteria — see the full checklist in the app.

Where this trial is running

• Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada

Who to contact

Patrick Nguyen, B. Pharm, M.Sc. · 514-890-8000 · patrick.nguyen.chum@ssss.gouv.qc.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06983080.