Actively Recruiting
The Efficacy of Trazodone for the Treatment of Insomnia in Older Adults: A Randomized Controlled Trial (The TRADITION Study)
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2025-12-08
40
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of trazodone in treating insomnia in adults aged 65 years and older. The main goal is to determine if trazodone reduces the severity of insomnia symptoms better than a placebo in this older population. This study is a randomized controlled trial sponsored by the Centre hospitalier de l'Universite de Montreal (CHUM). Participants are adults who meet criteria for insomnia according to ICSD-3R guidelines. Participants will receive either 25 to 50 mg of trazodone or a matching placebo once daily at bedtime for 28 days. After a 14-day break without treatment, they will switch to the other medication for an additional 28 days. This crossover design allows each participant to try both trazodone and placebo in sequence. The trazodone dose may be increased from 25 mg to 50 mg after 14 days. The study includes two treatment periods separated by a washout period. During the study, participants will visit the clinic three times for checkups and testing. They will complete a sleep diary and wear an actimeter (a device to measure movement) at night to track sleep patterns. Researchers will assess insomnia severity using the Insomnia Severity Index at the start, day 36, and day 77. Other sleep measures and potential side effects will also be monitored throughout the study. Total participation lasts approximately 12 weeks, including treatment and washout periods.
CONDITIONS
Brief Title
Efficacy of Trazodone to Treat Insomnia in Older Adults (TRADITION Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged 65 or older in an outpatient setting
- Diagnosis of insomnia according to ICSD-3R criteria
You will not qualify if you...
- Allergy or hypersensitivity to trazodone
- Ventricular cardiac arrhythmia such as torsades de pointes
- Myocardial infarction within the past 6 months
- Use of sleep-altering substances including hypnotics, mirtazapine, quetiapine, corticosteroids, melatonin, or psychostimulants
- Active or unstable psychiatric disorder
- Starting or adjusting antidepressants within the past 6 months
- Current or planned cognitive-behavioral therapy during the study
- Moderate or severe major neurocognitive disorder or other cognitive impairments preventing participation
- Parkinson's disease
- History of priapism
- Known angle-closure glaucoma
- Frequent symptomatic restless leg syndrome (more than 3 times per week)
- QTc interval greater than 500 milliseconds
- Parasomnias or dyssomnias other than insomnia
- Severe sleep apnea with apnea-hypopnea index over 30 without CPAP treatment
- Use of monoamine oxidase inhibitors
- Use of strong CYP 3A4 inducers or inhibitors
- Hospitalization during the study
- Seizure within the past 6 months
- History of orthostatic hypotension
- Delirium within the last 6 months
- Consuming more than 14 alcoholic drinks daily or using alcohol to induce sleep
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 70 days (two 28-day treatment periods separated by a 14-day washout)
Participants receive trazodone or placebo once daily at bedtime for 28 days, followed by a 14-day washout period, then crossover to the other treatment for another 28 days.
Visits at baseline, day 36, and day 77; daily symptom questionnaires during treatment weeks
Trial Site Locations
Total: 1 location
1
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X 0C1
Actively Recruiting
Research Team
P
Patrick Nguyen, B. Pharm, M.Sc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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