Your session is about to expire
← Back to Search
Antidepressant
Mirtazapine for Chronic Insomnia (MIRAGE Trial)
Montreal, Canada
Phase 1
Waitlist Available
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
Must not have
Parkinson's disease
Active psychiatric illness
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
Approved for 5 Other Conditions
All Individual Drugs Already Approved
Summary
This trial aims to test if mirtazapine, a sleep aid, is safe and effective for older adults with chronic insomnia. The study will involve people aged 65 and older over a few weeks. Researchers will measure how well it improves sleep and monitor any side effects. Mirtazapine has been shown to improve total sleep time, sleep efficiency, and sleep quality in previous studies.
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My sleep issues are due to chronic insomnia, not another sleep disorder.
Select...
I am 65 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have Parkinson's disease.
Select...
I am currently experiencing a psychiatric illness.
Select...
I have fallen more than once in the past 3 months.
Select...
I am currently taking melatonin.
Select...
I am taking medication for insomnia.
Timeline
Screening ~ 3 weeks3 visits
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)
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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Insomnia Severity Index
Pittsburgh Sleep Quality Index
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Mirtazapine 7.5 mg
Group II: ControlPlacebo Group1 Intervention
Matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirtazapine
FDA approved
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Chronic insomnia treatments often involve pharmacological agents that target specific neurotransmitter systems to promote sleep. Mirtazapine, for example, works by blocking histamine-1 receptors, which has a sedative effect that helps reduce sleep latency and increase total sleep time.
This is particularly beneficial for chronic insomnia patients as it directly addresses difficulties in falling and staying asleep. Other common treatments include benzodiazepines and Z-drugs (e.g., zolpidem), which enhance the effect of the neurotransmitter GABA to induce sedation.
However, these can have significant side effects such as cognitive impairment and risk of dependence. Melatonin, another treatment option, regulates the sleep-wake cycle and is generally well-tolerated.
Understanding these mechanisms is crucial for tailoring treatment to individual patient needs and minimizing potential side effects.
Drug treatment strategies for insomnia in patients with post-traumatic stress disorder.Acute effects of mirtazapine on sleep continuity and sleep architecture in depressed patients: a pilot study.
Drug treatment strategies for insomnia in patients with post-traumatic stress disorder.Acute effects of mirtazapine on sleep continuity and sleep architecture in depressed patients: a pilot study.
Find a Location
Closest Location:Centre Hospitalier de l'Université de Montréal· Montreal, Canada
Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
377 Previous Clinical Trials
131,460 Total Patients Enrolled
Quebec Researchnetwork on agingUNKNOWN
Patrick VQ NguyenPrincipal InvestigatorCentre de Recerche du CHUM
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience sleep problems and daytime issues at least 3 times a week.I have had sleep problems affecting my day for over 3 months.My sleep issues are due to chronic insomnia, not another sleep disorder.I have Parkinson's disease.I am currently experiencing a psychiatric illness.I have trouble falling or staying asleep.I am 65 years old or older.I have fallen more than once in the past 3 months.Severe problems with memory, thinking, or understanding.You have enough time and a good environment to sleep.I am currently taking melatonin.You have a medical reason that makes it unsafe for you to take mirtazapine.I have received Cognitive Behavioral Therapy for insomnia.I am taking medication for insomnia.You must experience at least one problem during the day because of your sleep issue.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
- Group 2: Control
Awards:
This trial has 2 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Insomnia Patient Testimony for trial: Trial Name: NCT05247697 — Phase 1