Chronic InsomniaPhase 1MIRAGENCT05247697
Mirtazapine for Chronic Insomnia in Older Adults
A Phase 1 study testing Mirtazapine 7.5 MG Oral Tablet once daily at bedtime in people with Chronic Insomnia, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- Mirtazapine 7.5 MG Oral Tablet once daily at bedtime
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2022to 30 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X0C1
About this study
Official title: Safety and Efficacy of Mirtazapine in the Treatment of Chronic Insomnia in Older Adults : The MIRAGE Study
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
- Being tested
- Mirtazapine 7.5 MG Oral Tablet once daily at bedtime, Placebo oral tablet once daily at bedtime
- Keywords
- Insomnia, Mirtazapine, Aged
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirtazapine 7.5 MG Oral Tablet once daily at bedtimeDrug
Mirtazapine 7,5 mg capsule
Placebo oral tablet once daily at bedtimeDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Mirtazapine 7.5 mg Receives: Drug: Mirtazapine 7.5 MG Oral Tablet once daily at bedtime |
| Control | Placebo comparator | Matching placebo Receives: Drug: Placebo oral tablet once daily at bedtime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
Self-reported insomnia symptoms using an insomnia severity scale from 0 to 28, 28 being the worst outcome
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start1 Oct 2022
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective double blind placebo controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Quebec Researchnetwork on aging
- Responsible party
- Sponsor
- Investigators
- Patrick VQ Nguyen, Principal investigator, Centre de Recerche du CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247697
- Sponsor's protocol ID
- 20.105
- Acronym
- MIRAGE
- Status last verified
- Aug 2024
- First submitted
- 12 Jan 2022
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40135470
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Mirtazapine in the Treatment of Chronic Insomnia in Older Adults : The MIRAGE Study
- ClinicalTrials.gov ID
- NCT05247697
- Acronym / sponsor ID
- MIRAGE / 20.105
- Conditions
- Chronic Insomnia
- Keywords
- Insomnia, Mirtazapine, Aged
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Quebec Researchnetwork on aging
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Prospective double blind placebo controlled trial
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Mirtazapine 7.5 MG Oral Tablet once daily at bedtimeMirtazapine 7.5 mg |
| Control | Placebo comparator | Drug: Placebo oral tablet once daily at bedtimeMatching placebo |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- Contrindication to mirtazapine
- Use of drug for insomnia
- Cognitive Behavioural Therapy for insomnia
- Use of Melatonin
- Active psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mirtazapine 7.5 MG Oral Tablet once daily at bedtimeMirtazapine 7,5 mg capsule | Drug | Treatment |
| Placebo oral tablet once daily at bedtimeMatching placebo | Drug | Control |
Primary outcome
Insomnia Severity Index
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)
Self-reported insomnia symptoms using an insomnia severity scale from 0 to 28, 28 being the worst outcome
Pittsburgh Sleep Quality Index
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)
Sleep scale from 0 to 21, 21 being the worst outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Derived from this study: PubMed 40135470Nguyen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick VQ Nguyen principal investigator
Centre de Recerche du CHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mirtazapine 7.5 MG Oral Tablet once daily at bedtime in people with Chronic Insomnia, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05247697, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.