Mirtazapine for Chronic Insomnia in Older Adults (MIRAGE)

Centre hospitalier de l'Université de Montréal (CHUM)

Status and phase: Completed; Phase 1

Conditions: Chronic Insomnia

Treatments: Drug: Placebo oral tablet once daily at bedtime; Drug: Mirtazapine 7.5 MG Oral Tablet once daily at bedtime

Study type: Interventional

Funder types: Other

Identifiers

NCT05247697

20.105

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

Mirtazapine 7.5 mg

Treatment:

Drug: Mirtazapine 7.5 MG Oral Tablet once daily at bedtime

Control

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo oral tablet once daily at bedtime