Status:
RECRUITING
Efficacy of Trazodone to Treat Insomnia in Older Adults (TRADITION Study)
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Conditions:
Insomnia Chronic
Older People
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief 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 i...
Eligibility Criteria
Inclusion
- Individuals aged 65 or older in an outpatient setting
- Insomnia according to the criteria of the ICSD-3R
Exclusion
- 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.
Key Trial Info
Start Date :
November 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06983080
Start Date
November 10 2025
End Date
December 1 2027
Last Update
December 8 2025
Active Locations (1)
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1
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X 0C1