Efficacy of Trazodone to Treat Insomnia in Older Adults (TRADITION Study)
Key facts
- Phase
- Phase 2
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Centre hospitalier de l'Université de Montréal (CHUM)
- Trial code
- NCT06983080
- Record updated
- 8 December 2025
- Original description
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 :Read full original descriptionShow less
The Efficacy of Trazodone for the Treatment of Insomnia in Older Adults: A Randomized Controlled Trial (The TRADITION Study)
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.
Inclusion: Individuals aged 65 or older in an outpatient setting; Insomnia according to the criteria of the ICSD-3R.
Exclusion: Substances that may alter sleep (hypnotics or any other medication intended to induce sleep, such as mirtazapine or quetiapine, corticosteroids, melatonin, psychostimulant drugs); Cognitive-behavioral therapy ongoing or planned during the study period; Use of a monoamine oxidase inhibitor; Use of a strong CYP 3A4 inducer or inhibitor; Contraindication to trazodone (hypersensitivity); Presence of a ventricular cardiac arrhythmia (e.g., torsades de pointes); Recent myocardial infarction (< 6 months); Active, unstable psychiatric disorder; 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; Symptomatic restless leg syndrome > 3 times per week; Seizure within the past 6 months; History of orthostatic hypotension; History of delirium within the last 6 months; QTc interval > 500 ms; Initiation or titration of an antidepressant within the past 6 months; Priapism; Known angle-closure glaucoma; Parasomnias, dyssomnias other than insomnia; Severe sleep apnea with AHI > 30 without CPAP treatment; Hospitalized individuals; Consumption of > 14 alcoholic drinks per day or use of alcohol to induce sleep.