Clinical trial NCT05247697: Mirtazapine for Chronic Insomnia in Older Adults
Official title: Safety and Efficacy of Mirtazapine in the Treatment of Chronic Insomnia in Older Adults : The MIRAGE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Insomnia
Keywords: Insomnia
Mirtazapine
Aged
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Quebec Researchnetwork on aging
First posted: 2022-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective double blind placebo controlled trial
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: 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)
measure: Pittsburgh Sleep Quality Index
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
affiliation: Centre de Recerche du CHUM
name: Patrick VQ Nguyen
role: PRINCIPAL_INVESTIGATOR
References: