Actively Recruiting

Phase 2
Age: 65Years +
All Genders
NCT06983080

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

Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2025-12-08

40

Participants Needed

1

Research Sites

107 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals aged 65 or older in an outpatient setting
  • Insomnia according to the criteria of the ICSD-3R
Not Eligible

You will not qualify if you...

  • Contraindication to trazodone (hypersensitivity)
  • Presence of a ventricular cardiac arrhythmia (e.g., torsades de pointes)
  • Recent myocardial infarction (< 6 months)
  • Use of substances that may alter sleep such as hypnotics, mirtazapine, quetiapine, corticosteroids, melatonin, or psychostimulant drugs
  • Active, unstable psychiatric disorder
  • Initiation or titration of an antidepressant within the past 6 months
  • Ongoing or planned cognitive-behavioral therapy during the study period
  • Moderate or severe major neurocognitive disorder or other cognitive disorders preventing participation
  • Parkinson's disease
  • Priapism
  • Known angle-closure glaucoma
  • Symptomatic restless leg syndrome more than 3 times per week
  • QTc interval greater than 500 ms
  • Parasomnias or dyssomnias other than insomnia
  • Severe sleep apnea with AHI greater than 30 without CPAP treatment
  • Use of a monoamine oxidase inhibitor
  • Use of a strong CYP 3A4 inducer or inhibitor
  • Hospitalized individuals
  • Seizure within the past 6 months
  • History of orthostatic hypotension
  • History of delirium within the last 6 months
  • Consumption of more than 14 alcoholic drinks per day or use of alcohol to induce sleep

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada, H2X 0C1

Actively Recruiting

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Research Team

P

Patrick Nguyen, B. Pharm, M.Sc.

CONTACT

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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