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.
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