Mirtazapine for Chronic Insomnia

(MIRAGE Trial)

Overseen By Philippe Desmarais

Age: 65+

Sex: Any

Trial Phase: Phase 1

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

Must not be taking: Benzodiazepines, Z-drugs, Melatonin

Disqualifiers: Active psychiatric illness, Parkinson's, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop using any drugs for insomnia, melatonin, or if you are undergoing Cognitive Behavioural Therapy for insomnia.

What data supports the effectiveness of the drug Mirtazapine for treating chronic insomnia?

Mirtazapine is often used in low doses to help with insomnia, and some studies suggest it can improve sleep continuity, especially in patients with depression. Additionally, esmirtazapine, a similar drug, has shown short-term sleep-promoting effects in people with chronic insomnia. ^{1 2 3 4 5}

How does the drug Mirtazapine differ from other treatments for chronic insomnia?

Mirtazapine is unique for treating chronic insomnia because it is primarily an antidepressant that can also help with sleep by affecting neurotransmitters (chemical messengers in the brain) like serotonin and norepinephrine, unlike traditional sleep medications that mainly target sleep directly. ^{6 7 8 9 10}

Research Team

Patrick VQ Nguyen

Principal Investigator

Centre de Recerche du CHUM

Eligibility Criteria

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.

Inclusion 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.

Exclusion Criteria

I have Parkinson's disease.

I am currently experiencing a psychiatric illness.

I have fallen more than once in the past 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mirtazapine 7.5 mg or placebo at bedtime for 28 days

4 weeks

Initial examination (Day 1) and end of treatment course (Day 36)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Mirtazapine

Trial Overview 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.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Mirtazapine 7.5 mg

Group II: Control Placebo Group 1 Intervention

Matching placebo

Mirtazapine is already approved in United States, European Union for the following indications:

Approved in United States as Remeron for:

• Major depressive disorder

Approved in European Union as Avanza for:

• Major depressive episodes

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Quebec Researchnetwork on aging

Collaborator

Trials

1

Recruited

60+

Findings from Research

A review of 24 studies involving 3,909 participants found that Z-drugs (zaleplon, zolpidem, zopiclone) and benzodiazepines show few clear differences in effectiveness for treating insomnia, indicating that both classes of drugs can be similarly effective.

Zaleplon may lead to quicker sleep onset but results in shorter total sleep duration compared to zolpidem, highlighting the importance of understanding the pharmacological profiles of these medications when considering treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy of newer hypnotic drugs for the short-term management of insomnia: a systematic review and meta-analysis. Dündar, Y., Dodd, S., Strobl, J., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Relationship between mirtazapine dose and incidence of adrenergic side effects: An exploratory analysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of esmirtazapine in adult outpatients with chronic primary insomnia: a randomized, double-blind placebo-controlled study and open-label extension. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of low-dose amitriptyline and mirtazapine for insomnia disorder: study protocol of a randomised, double-blind, placebo-controlled trial in general practice (the DREAMING study). [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Insomnia: Pharmacologic Therapy. [2017]

5. Germany pubmed.ncbi.nlm.nih.gov

Effects of mirtazapine on the sleep wake rhythm of geriatric patients with major depression: an exploratory study with actigraphy. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Response to oral and intravenous azithromycin in a patient with toxoplasma encephalitis and AIDS. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Treatment of antiviral-resistant recurrent erythema multiforme with dapsone. [2017]

8. Germany pubmed.ncbi.nlm.nih.gov

[The REM syndrome--alternative therapeutic possibilities]. [2013]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Cost-consequence model comparing eltrombopag versus romiplostim for adult patients with chronic immune thrombocytopenia. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Comparative efficacy of newer hypnotic drugs for the short-term management of insomnia: a systematic review and meta-analysis. [2018]