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Completed

NCT Number: NCT05247697

Mirtazapine for Chronic Insomnia in Older Adults

Insomnia is highly prevalent in the older adult population. The pharmacolgical management of chronic insomnia includes benzodiazepines and Z-drugs (zolpidem, zopiclone). Although these drugs are indicated for insomnia, they are not without side effects. These drugs are associated with cognitive impairment, rebound insomnia, falls and addiction. Mirtazapine has a hypnotic and sedative effect related to the blocking of histamine-1 receptors. No clinical trials has evaluated the efficacy and safety of mirtazapine for insomnia in the older population.

The goal of the study is to assess the efficacy and safety of mirtazapine compared to a placebo in older adults with chronic insomnia.

This prospective double-blind placebo controlled trial will be conducted in adults 65 years and older with chronic insomnia. The treatment group will receive mirtazapine 7.5 mg at bedtime for 28 days and the control group will receive a matching placebo for 28 days. The sample size for the pilot study will be 60 subjects, 30 subjects in the treatment group and 30 subjects in the control group. The efficacy of mirtazapine will be measured using the Insomnia Severity Index and the Pittsburgh Sleep Quality Index. Safety will be monitored during the study

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Key information

Conditions

Chronic Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X0C1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 65 years and older
  • A report of sleep initiation or maintenance problems
  • An adequate opportunity and circumstances to sleep,
  • To have at least one daytime consequence in relation to sleep complaint.
  • Sleep disorder and daytime consequences occur at least 3 times a week.
  • Duration of sleep disorder and daytime consequences for at least 3 months
  • Sleep complaint cannot be explained by a sleep disorder other than chronic insomnia.

Exclusion criteria

  • Contrindication to mirtazapine
  • Use of drug for insomnia
  • Cognitive Behavioural Therapy for insomnia
  • Use of Melatonin
  • Active psychiatric illness
  • Parkinson's disease
  • Major Neurocognitive disorders
  • More than one fall in the last 3 months

Treatment and study plan

Mirtazapine 7.5 MG Oral Tablet once daily at bedtime

Drug

Mirtazapine 7,5 mg capsule

Placebo oral tablet once daily at bedtime

Drug

Matching placebo

Primary outcomes

  1. Insomnia Severity Index

    Time frame: 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)

    Self-reported insomnia symptoms using an insomnia severity scale from 0 to 28, 28 being the worst outcome

  2. Pittsburgh Sleep Quality Index

    Time frame: For Mirtazapine and placebo group : Assess the change in the Pittsburgh Sleep Quality Index between the initial examination (Day 1) and the end of the treatment course (Day 36)

    Sleep scale from 0 to 21, 21 being the worst outcome

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • Quebec Researchnetwork on aging

Registry information

Official study title

Safety and Efficacy of Mirtazapine in the Treatment of Chronic Insomnia in Older Adults : The MIRAGE Study

Acronym: MIRAGE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2022
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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