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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.
Age
65 - No limit years
Sex
ALL
Healthy Volunteers
No
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Start Date
November 10, 2025
Primary Completion Date
July 1, 2027
Completion Date
December 1, 2027
Last Updated
December 8, 2025
40
ESTIMATED participants
Trazodone 25 mg
DRUG
Lead Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
NCT06807086
NCT06567210
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06793501