Mirtazapine for Chronic Insomnia in Older Adults

NCT05247697 | Completed Phase 1

• 1 other identifier: 20.105
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Insomnia

Keywords

Insomnia; Mirtazapine; Aged

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Study Arms (2)

Treatment

EXPERIMENTAL

Mirtazapine 7.5 mg

Drug: Mirtazapine 7.5 MG Oral Tablet once daily at bedtime

Control

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo oral tablet once daily at bedtime

Interventions

Mirtazapine 7.5 MG Oral Tablet once daily at bedtime DRUG

Mirtazapine 7,5 mg capsule

Treatment

Placebo oral tablet once daily at bedtime DRUG

Matching placebo

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Quebec Researchnetwork on aging: collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X0C1, Canada

Location

Related Publications (1)

• Nguyen PV, Dang-Vu TT, Forest G, Desjardins S, Forget MF, Vu TT, Nguyen QD, Kouassi E, Desmarais P. Mirtazapine for chronic insomnia in older adults: a randomised double-blind placebo-controlled trial-the MIRAGE study. Age Ageing. 2025 Mar 3;54(3):afaf050. doi: 10.1093/ageing/afaf050.

  PMID: 40135470 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Patrick VQ Nguyen

  Centre de Recerche du CHUM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective double blind placebo controlled trial

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: February 21, 2022
• Study Start: October 1, 2022
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)