Mirtazapine 7.5 MG Oral Tablet once daily at bedtime for Chronic Insomnia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Chronic InsomniaMirtazapine 7.5 MG Oral Tablet once daily at bedtime - Drug
Eligibility
65+
All Sexes
What conditions do you have?
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Study Summary

This trial will test whether mirtazapine is an effective and safe treatment for chronic insomnia in older adults.

Eligible Conditions
  • Chronic Insomnia

Video Summary

Treatment Effectiveness

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: For Mirtazapine and placebo group : Assess the change in the Insomnia Severity Index between the initial examination (Day 1) and the end of the treatment course (Day 36)

Day 36
Insomnia Severity Index
Day 36
Pittsburgh Sleep Quality Index

Trial Safety

Trial Design

2 Treatment Groups

Treatment
1 of 2
Control
1 of 2

Experimental Treatment

Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: Mirtazapine 7.5 MG Oral Tablet once daily at bedtime · Has Placebo Group · Phase 1

Treatment
Drug
Experimental Group · 1 Intervention: Mirtazapine 7.5 MG Oral Tablet once daily at bedtime · Intervention Types: Drug
Control
Drug
PlaceboComparator Group · 1 Intervention: Placebo oral tablet once daily at bedtime · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: for mirtazapine and placebo group : assess the change in the insomnia severity index between the initial examination (day 1) and the end of the treatment course (day 36)

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
326 Previous Clinical Trials
111,585 Total Patients Enrolled
Quebec Researchnetwork on agingUNKNOWN
Patrick VQ NguyenPrincipal InvestigatorCentre de Recerche du CHUM

Eligibility Criteria

Age 65+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Duration of sleep disorder and daytime consequences for at least 3 months.
You have at least one daytime consequence in relation to sleep complaint.
You have a sleep complaint that cannot be explained by a sleep disorder other than chronic insomnia.
You have sleep disorder and/or daytime consequences at least 3 times a week.