Clinical trial NCT06983080: Efficacy of Trazodone to Treat Insomnia in Older Adults (TRADITION Study)
Official title: The Efficacy of Trazodone for the Treatment of Insomnia in Older Adults: A Randomized Controlled Trial (The TRADITION Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Insomnia Chronic
Older People
Drug Therapy
Keywords: insomia
Trazodone
Older adults
randomized controlled trial
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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: 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.

Primary outcomes:
measure: Insomnia severity index
timeFrame: At baseline or at day 1, at day 36 and at day 77.
Secondary outcomes:
measure: Insomnia daytime symptoms and Impacts Questionnaire
timeFrame: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment
measure: Subjective Sleep onset latency
timeFrame: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment
measure: Subjective wake after sleep onset
timeFrame: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment
measure: Subjective Total sleep time
timeFrame: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment
measure: Subjective sleep efficiency
timeFrame: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment
measure: Objective sleep onset latency
timeFrame: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment
measure: Objective Wake After Sleep Onset
timeFrame: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment
measure: Objective Total Sleep Time
timeFrame: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment
measure: Objective Sleep Efficiency
timeFrame: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment
measure: Adverse events
timeFrame: At Day 36 and day 77
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
References: