Exogenous Melatonin in Postmenopausal Women with Insomnia

What this trial studies

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.

Conditions in scope

• Insomnia

Interventions

• Melatonin (Drug) — 2 Mg Oral Tablet, slow release
• Placebo (Drug) — placebo pill identical to the treatment pill

Who can join

Women only · Ages 45 Years to 65 Years

Inclusion criteria

• 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 criteria

• 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 wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Terminated
• Study type: Interventional
• Phase: N/A
• Start date: 2022-06-17
• Primary completion: 2024-12-31
• Last update posted: 2025-02-05
• First posted: 2022-07-01

Sponsor & contact

Lead sponsor: Douglas Mental Health University Institute (Other)

Collaborators: Canadian Institutes of Health Research (CIHR)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Change in sleep duration (Change from baseline sleep duration at treatment day 15)
  Sleep recorded with a portable device
• Change in wake after sleep onset (Change from baseline sleep duration at treatment day 15)
  Sleep recorded with a portable device
• Change in sleep efficiency (Change from baseline sleep duration at treatment day 15)
  Sleep recorded with a portable device
• Urinary 6-sulfatoxy-melatonin levels (During sleep periods during the last 3 days of each treatment phase)
  Urinary samples

Related ClearedRx care

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