Status:
TERMINATED
Exogenous Melatonin in Postmenopausal Women with Insomnia
Lead Sponsor:
Douglas Mental Health University Institute
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Insomnia
Eligibility:
FEMALE
45-65 years
Phase:
NA
Brief 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 rando...
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) ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
June 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05440734
Start Date
June 17 2022
End Date
December 31 2024
Last Update
February 5 2025
Active Locations (1)
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1
Centre for Study and Treatment of Circadian Rhythms
Montreal, Quebec, Canada, J4J5L8