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Recruiting NCT06983080

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

Phase II Interventional Insomnia Chronic Older People Drug Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Trazodone 25 mg.
Who it may be relevant to
Registry conditions: Insomnia Chronic, Older People, Drug Therapy. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Efficacy of Trazodone for the Treatment of Insomnia in Older Adults: A Randomized Controlled Trial (The TRADITION Study)

Overview

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.

Interventions

  • Drug Trazodone 25 mg
    Trazodone 25 mg at bedtime, which can be increased to 50 mg after 14 days of treatment.

Primary outcome measures

  • Insomnia severity index [Time frame: At baseline or at day 1, at day 36 and at day 77.]
Secondary outcome measures (10)
  • Insomnia daytime symptoms and Impacts Questionnaire [Time frame: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment]
  • Subjective Sleep onset latency [Time frame: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment]
  • Subjective wake after sleep onset [Time frame: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment]
  • Subjective Total sleep time [Time frame: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment]
  • Subjective sleep efficiency [Time frame: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment]
  • Objective sleep onset latency [Time frame: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment]
  • Objective Wake After Sleep Onset [Time frame: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment]
  • Objective Total Sleep Time [Time frame: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment]
  • Objective Sleep Efficiency [Time frame: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment]
  • Adverse events [Time frame: At Day 36 and day 77]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Centre Hospitalier de l'Université de Montréal — Montreal

Identifiers

NCT: NCT06983080 · 2025-12893

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗