Mirtazapine for Chronic Insomnia in Older Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-07-30

Brief Summary

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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

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Detailed Description

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Conditions

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Chronic Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective double blind placebo controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment

Mirtazapine 7.5 mg

Group Type EXPERIMENTAL

Mirtazapine 7.5 MG Oral Tablet once daily at bedtime

Intervention Type DRUG

Mirtazapine 7,5 mg capsule

Control

Matching placebo

Group Type PLACEBO_COMPARATOR

Placebo oral tablet once daily at bedtime

Intervention Type DRUG

Matching placebo

Interventions

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Mirtazapine 7.5 MG Oral Tablet once daily at bedtime

Mirtazapine 7,5 mg capsule

Intervention Type DRUG

Placebo oral tablet once daily at bedtime

Matching placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No