Chronic Insomnia
Conditions
Keywords
Insomnia, Mirtazapine, Aged
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
Interventions
DRUGMirtazapine 7.5 MG Oral Tablet once daily at bedtime
Mirtazapine 7,5 mg capsule
DRUGPlacebo oral tablet once daily at bedtime
Matching placebo
Sponsors
Quebec Researchnetwork on aging
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Prospective double blind placebo controlled trial
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index | 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 |
| Pittsburgh Sleep Quality Index | 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 |
Countries
Canada
Outcome results
None listed