Insomnia ChronicPhase 2TRADITIONNCT06983080
Efficacy of Trazodone to Treat Insomnia in Older Adults (TRADITION Study)
A Phase 2 study testing Trazodone 25 mg in people with Insomnia Chronic and Older People, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Insomnia Chronic, Older People, Drug Therapy
- What is being tested?
- Trazodone 25 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 10 Nov 2025to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Individuals aged 65 or older in an outpatient setting
- Insomnia according to the criteria of the ICSD-3R
Who cannot join
- 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
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0C1
Patrick Nguyen, B. Pharm. M.Sc., 514-890-8000 ext. 36163, patrick.nguyen.chum@ssss.gouv.qc.ca
Patrick Nguyen, B. Pharm. M.Sc.
About this study
Official title: The Efficacy of Trazodone for the Treatment of Insomnia in Older Adults: A Randomized Controlled Trial (The TRADITION Study)
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
- Being tested
- Trazodone 25 mg
- Keywords
- insomia, Trazodone, Older adults, randomized controlled trial
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trazodone 25 mgDrug
Trazodone 25 mg at bedtime, which can be increased to 50 mg after 14 days of treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Trazodone 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline or at day 1, at day 36 and at day 77.
Secondary outcomes (10)
Insomnia daytime symptoms and Impacts Questionnaire
The IDSIQ is a questionnaire covering 14 different items that specifically measures the impact of insomnia on various aspects of daytime functioning. The questions are grouped into three areas, each representing the main daytime symptoms and impacts of insomnia on drowsiness (four items), alertness/cognition (six items), and mood (four items). Each item is rated on an 11-point numerical scale (from 0 to 10), with lower scores indicating better daytime functioning. It has been found to be sensitive to changes in patients experiencing daytime effects. It is quick to administer, easy to complete, and has reliable reproducibility (test-retest). It can be used in clinical trials to assess changes and the effectiveness of a treatment on daytime functioning and for the recording of new drugs for insomnia. Regulatory authorities now require that the effectiveness of clinical trials for medical products against insomnia be measured not only by treating physicians but also by the p
Measured: 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
Subjective time duration, in minutes, between the time the participant attempts to fall asleep (e.g., lights off, lying in bed) and the time they perceive they have fallen asleep.
Measured: 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
The perceived total duration, in minutes, of all periods of wakefulness occurring after initial sleep onset and before final awakening
Measured: 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
The perceived total duration, in minutes, of actual sleep obtained during the night, excluding periods of wakefulness.
Measured: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment
Subjective sleep efficiency
The perceived percentage of time spent asleep while in bed, calculated as the ratio of subjective total sleep time (sTST) to time in bed (TIB), multiplied by 100
Measured: 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
The estimated duration, in minutes, between the time the participant attempts to fall asleep (e.g., lights out or bedtime) and the onset of the first sustained period of sleep, as detected by actigraphy
Measured: 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
The estimated total duration, in minutes, of wakefulness occurring after the initial sleep onset and before final awakening, as detected by actigraphy
Measured: 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
The estimated total duration, in minutes, of actual sleep obtained during the sleep period, as detected by actigraphy, excluding all periods of wakefulness
Measured: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment
Objective Sleep Efficiency
The estimated percentage of time spent asleep while in bed, calculated as the ratio of objective total sleep time (oTST) to objective time in bed (oTIB), multiplied by 100 as measured by actigraphy.
Measured: At baseline daily from day 1 to day 7, and during 7 days the first and last week of each treatment
Adverse events
Incidence of at least one adverse event. Incidence of severe adverse events. Proportion of participants who discontinued due to adverse events.
Measured: At Day 36 and day 77
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start10 Nov 2025
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983080
- Sponsor's protocol ID
- 2025-12893
- Other IDs
- 2025
- Acronym
- TRADITION
- Status last verified
- Dec 2025
- First submitted
- 27 Mar 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no need since it is a single center study.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Trazodone for the Treatment of Insomnia in Older Adults: A Randomized Controlled Trial (The TRADITION Study)
- ClinicalTrials.gov ID
- NCT06983080
- Acronym / sponsor ID
- TRADITION / 2025-12893
- Conditions
- Insomnia Chronic, Older People, Drug Therapy
- Keywords
- insomia, Trazodone, Older adults, randomized controlled trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crossover Trazodone then Placebo arm | Experimental | Drug: Trazodone 25 mgParticipants 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. |
| Crossover Placebo then Trazodone arm | Experimental | Drug: Trazodone 25 mgParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Individuals aged 65 or older in an outpatient setting
- Insomnia according to the criteria of the ICSD-3R
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trazodone 25 mgTrazodone 25 mg at bedtime, which can be increased to 50 mg after 14 days of treatment. | Drug | Crossover Placebo then Trazodone arm, Crossover Trazodone then Placebo arm |
Primary outcome
Insomnia severity index
Time frame: At baseline or at day 1, at day 36 and at day 77.
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No. There is no need since it is a single center study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trazodone 25 mg in people with Insomnia Chronic and Older People, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Nguyen, B. Pharm, M.Sc. (514-890-8000 ext. 36163, patrick.nguyen.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia severity index (time frame: At baseline or at day 1, at day 36 and at day 77.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.