Mirtazapine for Chronic Insomnia in Older Adults

Study Overview
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Brief Summary
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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

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

Conditions
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Chronic Insomnia

Intervention / Treatment
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* Drug: Mirtazapine 7.5 MG Oral Tablet once daily at bedtime
* Drug: Placebo oral tablet once daily at bedtime


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective double blind placebo controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Mirtazapine 7.5 mg | Drug: Mirtazapine 7.5 MG Oral Tablet once daily at bedtime<br>* Mirtazapine 7,5 mg capsule<br>|
| Placebo Comparator: Control<br>Matching placebo | Drug: Placebo oral tablet once daily at bedtime<br>* Matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index | Self-reported insomnia symptoms using an insomnia severity scale from 0 to 28, 28 being the worst outcome | 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) | 
| Pittsburgh Sleep Quality Index | Sleep scale from 0 to 21, 21 being the worst outcome | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Mirtazapine, Aged