Efficacy of Trazodone to Treat Insomnia in Older Adults (TRADITION Study)
NCT ID: NCT06983080
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2025-11-10
2027-12-31
Brief Summary
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\- 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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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.
Trazodone 25 mg
Trazodone 25 mg at bedtime, which can be increased to 50 mg after 14 days of treatment.
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.
Trazodone 25 mg
Trazodone 25 mg at bedtime, which can be increased to 50 mg after 14 days of treatment.
Interventions
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Trazodone 25 mg
Trazodone 25 mg at bedtime, which can be increased to 50 mg after 14 days of treatment.
Eligibility Criteria
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Inclusion Criteria
* Insomnia according to the criteria of the ICSD-3R
Exclusion Criteria
* 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.
65 Years
ALL
No
Sponsors
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Centre hospitalier de l'Université de Montréal (CHUM)
OTHER
Responsible Party
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Locations
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Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-12893
Identifier Type: -
Identifier Source: org_study_id
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