Insomnia Chronic study: Trazodone
Official title Efficacy of Trazodone to Treat Insomnia in Older Adults (TRADITION Study)
ClinicalTrials.gov ID: NCT06983080
What this study is testing
What is Trazodone 25 mg?
An investigational oral medication being studied for chronic insomnia in adults 65 and older.
Also referred to as Trazodone.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study compares trazodone to a placebo to see if it reduces insomnia symptoms in people 65 and older.
- Who it's for
- Adults 65 years or older who have chronic insomnia.
- What's involved
- Participants take 25–50 mg of trazodone or a matching placebo before bed for 28 days, then switch after a 2‑week break for another 28 days. They visit the clinic three times, keep a sleep diary, and wear an actimeter at night.
- Time commitment
- The study lasts 112 days (two 28‑day treatment periods with a 2‑week break) and requires three clinic visits and nightly sleep monitoring.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- Individuals aged 65 or older in an outpatient setting
- Insomnia according to the criteria of the ICSD-3R
You likely can't join 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...
- Active, unstable psychiatric disorder
- Initiation or titration of an antidepressant within the past 6 months
See the full eligibility criteria
- Individuals aged 65 or older in an outpatient setting
- Insomnia according to the criteria of the ICSD-3R
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.