Recruiting
Phase 2

Trazodone

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT06983080

Conditions

Insomnia Chronic

Older People

Drug Therapy

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Trazodone 25 mg

Study Details

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

Study ID

NCT06983080

Start date

Nov 10, 2025

Status verified date

Dec, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Crossover Trazodone then Placebo arm

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.

experimental: Crossover Placebo then Trazodone arm

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.

Interventions

Trazodone 25 mg

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

Primary outcome measure

  • Insomnia severity index [ Time Frame: At baseline or at day 1, at day 36 and at day 77. ]

Central Contacts and Locations

Central contacts

Patrick Nguyen, B. Pharm, M.Sc.

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

Locations

Centre Hospitalier de l'Université de Montréal

Recruiting

Montreal, Quebec, Canada, H2X 0C1

Contacts

Patrick Nguyen, B. Pharm. M.Sc.

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

Principal Investigator:

Patrick Nguyen, B. Pharm. M.Sc.

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Dec 8, 2025

Last verified

Dec, 2025

Keywords

  • insomia
  • Trazodone
  • Older adults
  • randomized controlled trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2025-12-08.