Efficacy of Trazodone to Treat Insomnia in Older Adults (TRADITION Study)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
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 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.
Eligibility criteria
Qualifiers
Individuals aged 65 or older in an outpatient setting
Insomnia according to the criteria of the ICSD-3R
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Trazodone 25 mg
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov