drugset / Trial / NCT06983080

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

NCT06983080

Phase 2 Recruiting 40 enrolled University of Montreal Hospital Centre (CHUM)
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2025-11-10
Primary completion
2027-07
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Trazodone Small molecule 50 mg

Indications