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Antidepressant

Mirtazapine for Chronic Insomnia (MIRAGE Trial)

Phase 1
Recruiting
Led By Patrick VQ Nguyen
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Sleep complaint cannot be explained by a sleep disorder other than chronic insomnia
Age 65 years and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights

MIRAGE Trial Summary

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

Who is the study for?
This trial is for older adults aged 65 and over who have chronic insomnia, which means they have trouble falling or staying asleep. Participants should experience these sleep issues at least three times a week with daytime consequences for more than three months. They can't join if they've had multiple falls recently, use melatonin or other insomnia drugs, are undergoing cognitive therapy for insomnia, have major neurocognitive disorders, Parkinson's disease, or an active psychiatric illness.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of Mirtazapine (7.5 mg) against a placebo in treating chronic insomnia among older adults. It's a double-blind trial where neither participants nor researchers know who gets the real medicine versus the placebo. The treatment lasts for 28 days with assessments using sleep quality indexes.See study design
What are the potential side effects?
While not specified here, common side effects of Mirtazapine may include drowsiness, increased appetite leading to weight gain, dry mouth, constipation and fatigue. As it has sedative effects related to blocking certain receptors in the brain.

MIRAGE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My sleep issues are due to chronic insomnia, not another sleep disorder.
Select...
I am 65 years old or older.

MIRAGE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Insomnia Severity Index
Pittsburgh Sleep Quality Index

MIRAGE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Mirtazapine 7.5 mg
Group II: ControlPlacebo Group1 Intervention
Matching placebo

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,577 Total Patients Enrolled
Quebec Researchnetwork on agingUNKNOWN
Patrick VQ NguyenPrincipal InvestigatorCentre de Recerche du CHUM

Media Library

Mirtazapine (Antidepressant) Clinical Trial Eligibility Overview. Trial Name: NCT05247697 — Phase 1
Chronic Insomnia Research Study Groups: Treatment, Control
Chronic Insomnia Clinical Trial 2023: Mirtazapine Highlights & Side Effects. Trial Name: NCT05247697 — Phase 1
Mirtazapine (Antidepressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05247697 — Phase 1
Chronic Insomnia Patient Testimony for trial: Trial Name: NCT05247697 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How likely is it that Mirtazapine 7.5 MG Oral Tablet once daily at bedtime will cause adverse effects in patients?

"Our team at Power assigned mirtazapine 7.5 MG Oral Tablet taken once a day before sleeping with an overall safety score of 1, as this is the initial phase in testing its effectiveness and potential risks."

Answered by AI

Is this research initiative currently enrolling participants?

"Clinicaltrials.gov has indicated that the study, originally posted on September 1st 2022, is no longer actively recruiting participants. However, there are still 207 other clinical trials with open enrollment at this time."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What site did they apply to?
Centre Hospitalier de l'Université de Montréal
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I’ve tried 3 different sleeping pills and followed CBT recommendations, but my insomnia is still crippling.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

When does the study start?
PatientReceived no prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. Centre Hospitalier de l'Université de Montréal: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Mirtazapine for Chronic Insomnia in Older Adults
2022. "Mirtazapine for Chronic Insomnia in Older Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05247697.
All > Sleep Disorders > Insomnia
~12 spots leftby Sep 2024
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