Mirtazapine for Chronic Insomnia in Older Adults (MIRAGE)
Primary Purpose
Chronic Insomnia
Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Mirtazapine 7.5 MG Oral Tablet once daily at bedtime
Placebo oral tablet once daily at bedtime
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Insomnia focused on measuring Insomnia, Mirtazapine, Aged
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier de l'Université de MontréalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Control
Arm Description
Mirtazapine 7.5 mg
Matching placebo
Outcomes
Primary Outcome Measures
Insomnia Severity Index
Self-reported insomnia symptoms using an insomnia severity scale from 0 to 28, 28 being the worst outcome
Pittsburgh Sleep Quality Index
Sleep scale from 0 to 21, 21 being the worst outcome
Secondary Outcome Measures
Full Information
NCT ID
NCT05247697
First Posted
January 12, 2022
Last Updated
December 12, 2022
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Quebec Researchnetwork on aging
1. Study Identification
Unique Protocol Identification Number
NCT05247697
Brief Title
Mirtazapine for Chronic Insomnia in Older Adults
Acronym
MIRAGE
Official Title
Safety and Efficacy of Mirtazapine in the Treatment of Chronic Insomnia in Older Adults : The MIRAGE Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Quebec Researchnetwork on aging
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Insomnia
Keywords
Insomnia, Mirtazapine, Aged
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Prospective double blind placebo controlled trial
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Mirtazapine 7.5 mg
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
Mirtazapine 7.5 MG Oral Tablet once daily at bedtime
Intervention Description
Mirtazapine 7,5 mg capsule
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet once daily at bedtime
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Insomnia Severity Index
Description
Self-reported insomnia symptoms using an insomnia severity scale from 0 to 28, 28 being the worst outcome
Time Frame
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)
Title
Pittsburgh Sleep Quality Index
Description
Sleep scale from 0 to 21, 21 being the worst outcome
Time Frame
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick VQ Nguyen
Phone
514-890-8000
Ext
36163
Email
patrick.nguyen.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Desmarais
Phone
514-890-8000
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick VQ Nguyen
Organizational Affiliation
Centre de Recerche du CHUM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X0C1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick VQ Nguyen
Phone
5148908000
Email
patrick.nguyen.chum@ssss.gouv.qc.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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Mirtazapine for Chronic Insomnia in Older Adults
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