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Efficacy of Trazodone to Treat Insomnia in Older Adults (TRADITION Study)

NCT06983080 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-08

No results posted yet for this study

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

Interventions

DRUG

Trazodone 25 mg

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

Sponsors & Collaborators

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-10
Primary Completion
2027-07-31
Completion
2027-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06983080 on ClinicalTrials.gov