NCT06983080

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

The Efficacy of Trazodone for the Treatment of Insomnia in Older Adults: A Randomized Controlled Trial (The TRADITION Study)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia Chronic
• Older People
• Drug Therapy

Interventions

Type	Name	Description
DRUG	Trazodone 25 mg	Trazodone 25 mg at bedtime, which can be increased to 50 mg after 14 days of treatment.

Timeline

• Start date: 2025-11-10
• Primary completion: 2027-07-01
• Completion: 2027-12-01
• First posted: 2025-05-21
• Last updated: 2025-12-08

Locations

1 site across 1 country: Canada