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Can a common antidepressant help seniors sleep better?

NCT ID NCT06983080

Symptom relief Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether trazodone, a medication often used for depression, can improve sleep in adults aged 65 and older with chronic insomnia. Forty participants will take either trazodone or a placebo for 28 days, then switch after a break. They will track their sleep with diaries and activity monitors to see if the drug reduces insomnia symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
trazodone
What this could lead to
If it works, this could offer a safe, non-habit-forming sleep aid for older adults with chronic insomnia.
What could go wrong
This is a small, early-phase trial with only 40 participants. The results may not apply to everyone, and trazodone can cause side effects like drowsiness or dizziness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

insomnia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Drug therapy Insomnia chronic Older people

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centre Hospitalier de l'Université de Montréal

    RECRUITING

    Montreal, Quebec, H2X 0C1, Canada

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