Trazodone for insomnia in adults 65 and older

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2, randomized, placebo-controlled crossover trial gives participants 25–50 mg of trazodone or a matching placebo each night for 28 days, followed by a 2-week washout and 28 days on the alternate treatment. Participants keep a sleep diary, wear a night-time actimeter, and attend three clinic visits for checks and outcome measures. The trial enrolls outpatient adults aged 65 and older who meet ICSD-3R criteria for chronic insomnia and excludes those with contraindications to trazodone or major medical/psychiatric conditions that affect sleep. Outcomes focus on change in insomnia severity and objective sleep measures over the treatment periods.

Why it matters

Who can join: the full rules

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 infarction (\< 6 months)
* Substances that may alter sleep (hypnotics or any other medication intended to induce sleep, such as mirtazapine or quetiapine, corticosteroids, melatonin, psychostimulant drugs)
* Active, unstable psychiatric disorder
* Initiation or titration of an antidepressant within the past 6 months
* Cognitive-behavioral therapy ongoing or planned during the study period
* Major neurocognitive disorder (NCD) moderate or severe, or other cognitive disorders that may prevent the participant from being able to participate in the study, according to the judgment of the evaluating physician
* Parkinson's disease
* Priapism
* Known angle-closure glaucoma
* Symptomatic restless leg syndrome \> 3 times per week
* QTc interval \> 500 ms
* Parasomnias, dyssomnias other than insomnia
* Severe sleep apnea with AHI \> 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 \> 14 alcoholic drinks per day or use of alcohol to induce sleep.

Where it's running

• Centre Hospitalier de l'Université de Montréal
  Montreal, Quebec, Canada Recruiting

Study contacts

• Study coordinator: Patrick Nguyen, B. Pharm, M.Sc.
• Email: patrick.nguyen.chum@ssss.gouv.qc.ca
• Phone: 514-890-8000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.