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

NCT06983080 | Recruiting Phase 2

• 1 other identifier: 2025-12893
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Chronic; Older People; Drug Therapy

Keywords

insomia; Trazodone; Older adults; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Insomnia severity index

  The ISI is a self-assessment questionnaire that evaluates the nature, severity, and impact of insomnia. The typical recall period is the past month. The dimensions assessed are: the severity of falling asleep, maintaining sleep, and waking up too early in the morning; sleep dissatisfaction; the interference of sleep difficulties with daytime functioning; the visibility of sleep problems to others; and the distress caused by sleep difficulties. A 5-point Likert scale is used to evaluate each item. The total score is interpreted as follows: no insomnia 0-7; subclinical insomnia 8-14; moderate insomnia 15-21; and severe insomnia 22-28. It is increasingly used as a measure of treatment response in clinical research. Data confirm its reliability and the validity of the measurements obtained in the older adult population.

  At baseline or at day 1, at day 36 and at day 77.

Secondary Outcomes (10)

• Insomnia daytime symptoms and Impacts Questionnaire

  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

  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

  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

  At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment

• Subjective sleep efficiency

  At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment

Study Arms (2)

Crossover Trazodone then Placebo arm

EXPERIMENTAL

Participants will receive 25 to 50 mg of trazodone once daily at bedtime for 28 days. After a 14-day washout period, participants will receive a placebo for another 28 days.

Drug: Trazodone 25 mg

Crossover Placebo then Trazodone arm

EXPERIMENTAL

Participants will receive a placebo once daily at bedtime for 28 days. After a 14-day washout period, participants will receive 25 to 50 mg of trazodone for another 28 days.

Drug: Trazodone 25 mg

Interventions

Trazodone 25 mg DRUG

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

Crossover Placebo then Trazodone arm; Crossover Trazodone then Placebo arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Individuals aged 65 or older in an outpatient setting
• Insomnia according to the criteria of the ICSD-3R

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0C1, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Trazodone

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridones; Pyridines

Central Study Contacts

Patrick Nguyen, B. Pharm, M.Sc.

CONTACT

514-890-8000; patrick.nguyen.chum@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: May 21, 2025
• Study Start: November 10, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)