InsomniaNCT05440734
Exogenous Melatonin in Postmenopausal Women with Insomnia
A study testing Melatonin in people with Insomnia, run by Douglas Mental Health University Institute at 1 site in Canada.
Trial summary
The aim of the study is to assess the effect of exogenous melatonin, 2 mg SR, 60 minutes before bedtime for 15 days, on the sleep and circadian rhythms of postmenopausal women with insomnia in a randomized crossover placebo-controlled study. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Insomnia
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jun 2022to 31 Dec 2024
- Phase
- Interventional
- 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Insomniac women will meet the diagnostic criteria for persistent insomnia as described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). They will report subjective sleep onset and/or maintenance difficulties associated with impaired daytime functioning at least 3 times a week, for at least 3 months. Sleep disturbances will be coincident with the onset of the menopausal transition.
- Postmenopausal women will have amenorrhea for at least 12 months.
- Participants will be drug-free at the time of study, and will have a history of only moderate or no use of coffee (≤3 cups/day), tobacco (≤ 10 cigarettes/day), alcohol (≤ 15 drinks/week), or other compounds.
Who cannot join
- Evidence of psychopathology on the Structured Clinical Interview for DSM-5, the Seasonal Pattern Assessment Questionnaire, the Beck Depression Inventory, and the Spielberger State Trait Anxiety Inventory.
- A history of prior gynecological pathology or medical condition that can affect the study results, including bilateral oophorectomy or endocrinopathy, and will not have used investigational drugs within 4 weeks of the study.
- A history of night work or transmeridian travel (across >2 time zones) in the 2 months prior to the study.
- Evidence of sleep apnea (apnea/hypopnea index > 15 per hour of sleep) or restless legs, or periodic limb movements during sleep (number of PLMs >15 per hour of sleep).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Study and Treatment of Circadian Rhythms
Montreal, Quebec, J4J5L8
About this study
Official title: Sleep and Circadian Rhythms in Men and Women - Protocol 4
The aim of the study is to assess the effect of exogenous melatonin, 2 mg SR, 60 minutes before bedtime for 15 days, on the sleep and circadian rhythms of postmenopausal women with insomnia in a randomized crossover placebo-controlled study.
Read the detailed description
Eligible participants will be contacted by the research team to provide informed consent for the study. Once the screening phase is completed, they will be ready to start the study consisting of:
- a ~2-week ambulatory phase at home with melatonin or placebo treatment; B) a 2-week wash-out period; C) same as A with the opposite treatment;
Part A: The research project will start with a 16-day ambulatory data-collection period during which participants will receive either melatonin or a placebo. They will take 2 mg of exogenous melatonin in a slow release formulation (or placebo), 60 mins prior to bedtime for 15 days. Participants will be instructed to go to bed at a regular time and stay in darkness for 8 consecutive hours each night, trying to sleep.
Part B: Throughout this period, all participants will stop taking their melatonin/placebo pills. After at least 2 weeks, they will prepare to participate to the other study condition.
Parts C: Repetition of Ambulatory phase 1 (Part A) except that participants who received the active treatment will now receive placebo and vice versa.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
2 Mg Oral Tablet, slow release
PlaceboDrug
placebo pill identical to the treatment pill
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Experimental | 2 mg oral tablet, melatonin slow release formulation, 1x 60 min before bedtime for 15 days Receives: Drug: Melatonin |
| Placebo | Placebo comparator | 2 mg oral tablet, 1x 60 min before bedtime for 15 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep duration
Sleep recorded with a portable device
Measured: Change from baseline sleep duration at treatment day 15
Change in wake after sleep onset
Sleep recorded with a portable device
Measured: Change from baseline sleep duration at treatment day 15
Change in sleep efficiency
Sleep recorded with a portable device
Measured: Change from baseline sleep duration at treatment day 15
Urinary 6-sulfatoxy-melatonin levels
Urinary samples
Measured: During sleep periods during the last 3 days of each treatment phase
Secondary outcomes (2)
Change in sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI)
A self-rated 19-item questionnaire, each of which has a range of 0 (no difficulty) to 3 (severe difficulty) points.These 19 items are combined to form 7 component scores reflecting different aspects of sleep quality. The 7 component scores are then added to yield one global score, with a range of 0-21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all area.
Measured: Change between treatment conditions in PSQI score at treatment day 15
Nocturnal skin temperature
Skin measured around the nocturnal sleep periods
Measured: Change between treatment conditions at bedtime at treatment days 14-15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start17 Jun 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover placebo-controlled study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Douglas Mental Health University Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Dr. Diane B. Boivin, Douglas Mental Health University Institute
- Investigators
- Diane B Boivin, MD, PhD, Principal investigator, Douglas Hospital Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440734
- Sponsor's protocol ID
- 2018-175
- Status last verified
- Feb 2025
- First submitted
- 17 Jun 2022
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Circadian Rhythms in Men and Women - Protocol 4
- ClinicalTrials.gov ID
- NCT05440734
- Acronym / sponsor ID
- 2018-175
- Conditions
- Insomnia
- Keywords
- menopause, aging, melatonin, circadian rhythms, sleep, alertness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Douglas Mental Health University InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 1 Jul 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.
The aim of the study is to assess the effect of exogenous melatonin, 2 mg SR, 60 minutes before bedtime for 15 days, on the sleep and circadian rhythms of postmenopausal women with insomnia in a randomized crossover placebo-controlled study.
Detailed description
Eligible participants will be contacted by the research team to provide informed consent for the study. Once the screening phase is completed, they will be ready to start the study consisting of:
- a ~2-week ambulatory phase at home with melatonin or placebo treatment; B) a 2-week wash-out period; C) same as A with the opposite treatment;
Part A: The research project will start with a 16-day ambulatory data-collection period during which participants will receive either melatonin or a placebo. They will take 2 mg of exogenous melatonin in a slow release formulation (or placebo), 60 mins prior to bedtime for 15 days. Participants will be instructed to go to bed at a regular time and stay in darkness for 8 consecutive hours each night, trying to sleep.
Part B: Throughout this period, all participants will stop taking their melatonin/placebo pills. After at least 2 weeks, they will prepare to participate to the other study condition.
Parts C: Repetition of Ambulatory phase 1 (Part A) except that participants who received the active treatment will now receive placebo and vice versa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized crossover placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Experimental | Drug: Melatonin2 mg oral tablet, melatonin slow release formulation, 1x 60 min before bedtime for 15 days |
| Placebo | Placebo comparator | Drug: Placebo2 mg oral tablet, 1x 60 min before bedtime for 15 days |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Insomniac women will meet the diagnostic criteria for persistent insomnia as described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). They will report subjective sleep onset and/or maintenance difficulties associated with impaired daytime functioning at least 3 times a week, for at least 3 months. Sleep disturbances will be coincident with the onset of the menopausal transition.
- Postmenopausal women will have amenorrhea for at least 12 months.
- Participants will be drug-free at the time of study, and will have a history of only moderate or no use of coffee (≤3 cups/day), tobacco (≤ 10 cigarettes/day), alcohol (≤ 15 drinks/week), or other compounds.
Key exclusion criteria (4 listed)
- Evidence of psychopathology on the Structured Clinical Interview for DSM-5, the Seasonal Pattern Assessment Questionnaire, the Beck Depression Inventory, and the Spielberger State Trait Anxiety Inventory.
- A history of prior gynecological pathology or medical condition that can affect the study results, including bilateral oophorectomy or endocrinopathy, and will not have used investigational drugs within 4 weeks of the study.
- A history of night work or transmeridian travel (across >2 time zones) in the 2 months prior to the study.
- Evidence of sleep apnea (apnea/hypopnea index > 15 per hour of sleep) or restless legs, or periodic limb movements during sleep (number of PLMs >15 per hour of sleep).
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 |
|---|---|---|
| Melatonin2 Mg Oral Tablet, slow release | Drug | Melatonin |
| Placeboplacebo pill identical to the treatment pill | Drug | Placebo |
Primary outcome
Change in sleep duration
Time frame: Change from baseline sleep duration at treatment day 15
Sleep recorded with a portable device
Change in wake after sleep onset
Time frame: Change from baseline sleep duration at treatment day 15
Sleep recorded with a portable device
Change in sleep efficiency
Time frame: Change from baseline sleep duration at treatment day 15
Sleep recorded with a portable device
Urinary 6-sulfatoxy-melatonin levels
Time frame: During sleep periods during the last 3 days of each treatment phase
Urinary samples
2 secondary outcomes
Change in sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change between treatment conditions in PSQI score at treatment day 15
Nocturnal skin temperature
Time frame: Change between treatment conditions at bedtime at treatment days 14-15
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- 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.
Diane B Boivin, MD, PhD principal investigator
Douglas Hospital Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin in people with Insomnia, run by Douglas Mental Health University Institute 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 5 Feb 2025. 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.
Are results available for this study?
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
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?
Change in sleep duration (time frame: Change from baseline sleep duration at treatment day 15). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2025.