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

Recruiting Phase 2 Interventional Study
Insomnia Chronic Older People Drug Therapy
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
65 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM) · Other
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About This Trial
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 t…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Individuals aged 65 or older in an outpatient setting * Insomnia according to the criteria of the ICSD-3R Exclusion Criteria: * Contraindication to trazodone (hypersensitivity) * Presence of a ventricular cardiac arrhythmia (e.g., torsades de pointes) * Recent myocardial inf…
Contacts

Patrick Nguyen, B. Pharm, M.Sc.

514-890-8000

patrick.nguyen.chum@ssss.gouv.qc.ca

CONTACT