Clinical Trial

Efficacy of Trazodone to Treat Insomnia in Older Adults (TRADITION Study)

Study acronym: TRADITION
Recruiting Phase 2
View on ClinicalTrials.gov →
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 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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-13.
Status change: Not Yet Recruiting → Recruiting 2025-12-02
Trial Details
NCT Number NCT06983080
Lead Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Conditions Insomnia Chronic, Older People, Drug Therapy
Enrollment 40 participants
Start Date 2025-11-10
Primary Completion 2027-07 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2025-12-08