Mirtazapine for Chronic Insomnia in Older Adults

Phase 1

Completed

• Conditions: Chronic Insomnia
• Interventions: Drug: Mirtazapine 7.5 MG Oral Tablet once daily at bedtime; Drug: Placebo oral tablet once daily at bedtime

• Registration Number: NCT05247697
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-02-09
• Study First Posted: 2022-02-21
• Study Start: 2022-10-01
• Primary Completion: 2024-07-30
• Study Completion: 2024-07-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Mirtazapine 7.5 MG Oral Tablet once daily at bedtime	Mirtazapine 7.5 mg
Control	Placebo oral tablet once daily at bedtime	Matching placebo

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre Hospitalier de l'Université de Montréal; 🇨🇦 Montreal, Quebec, Canada