Trazodone for Insomnia in Seniors

(TRADITION Trial)

Overseen By Patrick Nguyen, B. Pharm, M.Sc.

Age: 65+

Sex: Any

Trial Phase: Phase 2

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Must not be taking: Hypnotics, Corticosteroids, Melatonin, others

Disqualifiers: Cardiac arrhythmia, Psychiatric disorder, Neurocognitive disorder, Parkinson's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 10 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

The TRADITION study is for older adults aged 65 and over who are experiencing chronic insomnia. Participants will take trazodone or a placebo before bed for a period, with clinic visits and sleep monitoring involved. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

I have been diagnosed with insomnia.

I am 65 or older and not hospitalized.

Exclusion Criteria

I experience restless leg syndrome symptoms more than 3 times a week.

I am not taking medication that strongly affects liver enzyme activity.

Contraindication to trazodone (hypersensitivity)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 25 to 50 mg of trazodone or placebo before bed for 28 days, followed by a 14-day washout, then switch to the other medication for another 28 days

10 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Trazodone

Trial Overview This trial tests the effectiveness of Trazodone (25 to 50 mg) in reducing insomnia symptoms compared to a placebo in seniors. It's designed as a crossover study where participants switch between the drug and placebo after an initial treatment phase followed by a break.

Participant Groups

Group I: Crossover Trazodone then Placebo arm Experimental Treatment 1 Intervention

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.

Group II: Crossover Placebo then Trazodone arm Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+