Mirtazapine for Chronic Insomnia in Older Adults

Chronic Insomnia Clinical Trial

— MIRAGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05247697
• Other study ID #: 20.105
• Status: Recruiting
• Phase: Phase 1
• Start date: September 1, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2022
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: Patrick VQ Nguyen
• Phone: 514-890-8000
• Email: patrick.nguyen.chum[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Mirtazapine 7.5 MG Oral Tablet once daily at bedtime
Mirtazapine 7,5 mg capsule
• Placebo oral tablet once daily at bedtime
Matching placebo

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)	Quebec Researchnetwork on aging

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)