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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of mirtazapine for older adults with chronic insomnia. Mirtazapine may improve sleep without the unwanted side effects common with other sleep medications. The study compares mirtazapine to a placebo (a dummy pill) to determine its effectiveness and safety. Researchers seek adults aged 65 and older who have trouble sleeping at least three times a week and experience daytime issues as a result. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this treatment.

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.

Is there any evidence suggesting that mirtazapine is likely to be safe for humans?

Research has shown that mirtazapine can be a safe choice for treating insomnia. In earlier studies, mirtazapine significantly reduced insomnia severity compared to a placebo. At a low dose, it improved sleep quality and reduced nighttime awakenings.

While researchers are now testing mirtazapine for insomnia, it is already approved for other uses, indicating it has passed previous safety checks. Some people have experienced side effects, but these are usually mild. Always consult a healthcare provider about possible risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike most treatments for chronic insomnia that primarily focus on altering sleep-wake cycles or enhancing relaxation, Mirtazapine offers a different approach. Mirtazapine is an antidepressant that works by increasing certain neurotransmitters in the brain, which may help improve sleep quality. Researchers are excited about Mirtazapine because it could provide benefits for those with chronic insomnia who haven't found relief with traditional sleep aids. Additionally, its potential dual action—addressing both sleep and mood—could be particularly advantageous for individuals experiencing insomnia linked with mood disorders.

What evidence suggests that mirtazapine might be an effective treatment for chronic insomnia?

Research has shown that mirtazapine, which participants in this trial may receive, can help treat long-term insomnia. One study found that taking mirtazapine for 28 days significantly reduced insomnia symptoms compared to a placebo. Another study discovered that a low dose of mirtazapine improved insomnia symptoms after six weeks. Participants taking mirtazapine reported better sleep quality and fewer awakenings during the night. These results suggest that mirtazapine may improve sleep in older adults with chronic insomnia. ^{1 3 5 6 7}

Who Is on the Research Team?

Patrick VQ Nguyen

Principal Investigator

Centre de Recerche du CHUM

Are You a Good Fit for This Trial?

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.

Severe problems with memory, thinking, or understanding.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40135470/

Mirtazapine for chronic insomnia in older adults

Our findings show that a 28-day treatment with mirtazapine, compared to placebo, significantly reduces insomnia severity, as measured by the ...

2.

academic.oup.com

academic.oup.com/ageing/article/54/3/afaf050/8093583?login=true

Mirtazapine for chronic insomnia in older adults: a randomised ...

Our findings show that a 28-day treatment with mirtazapine, compared to placebo, significantly reduces insomnia severity, as measured by the ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12199994/

Effectiveness of low-dose amitriptyline and mirtazapine in ...

Low-dose mirtazapine provided a statistically significant and clinically relevant reduction of insomnia severity at 6 weeks, but not at later time points.

4.

karger.com

karger.com/nps/article/doi/10.1159/000547983/934022/Therapeutic-Effects-and-Safety-of-Mirtazapine-for

Therapeutic Effects and Safety of Mirtazapine for Insomnia ...

On day 14, with a mean dose of 18.9 mg/day, 24.8% of patients experienced remission for insomnia, while 7.3% showed remission for depression. By ...

5.

journals.lww.com

journals.lww.com/ebp/fulltext/2022/05000/in_adult_patients,_is_mirtazapine_safe_and.1.aspx

In adult patients, is mirtazapine safe and effective for...

Patients in the 4.5-mg group reported having a significant reduction in waking after sleep onset (1.2 vs 1.6 awakenings, P<.01), perceived sleep quality (52.7 ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10732122/

Efficacy and safety of pharmacotherapy in chronic insomnia

This review compares recommendations from 3 clinical guidelines and summarizes hypnotic medications, including their newly reported side effects not mentioned ...

7.

bjgp.org

bjgp.org/content/75/756/e474

Effectiveness of low-dose amitriptyline and mirtazapine in ...

Conclusion Compared with placebo, low-dose mirtazapine provided a statistically significant and clinically relevant reduction of insomnia severity at 6 weeks, ...