NCT05247697

Mirtazapine for Chronic Insomnia in Older Adults

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chronic Insomnia

Interventions

Type	Name	Description
DRUG	Mirtazapine 7.5 MG Oral Tablet once daily at bedtime	Mirtazapine 7,5 mg capsule
DRUG	Placebo oral tablet once daily at bedtime	Matching placebo

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-07-30
• Completion: 2024-07-30
• First posted: 2022-02-21
• Last updated: 2024-08-12

Locations

1 site across 1 country: Canada