Exogenous Melatonin in Postmenopausal Women with Insomnia

NCT05440734 | Terminated

• 1 other identifier: 2018-175
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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 randomized crossover placebo-controlled study.

Conditions

Insomnia

Keywords

menopause; aging; melatonin; circadian rhythms; sleep; alertness

Outcome Measures

Primary Outcomes (4)

• Change in sleep duration

  Sleep recorded with a portable device

  Change from baseline sleep duration at treatment day 15

• Change in wake after sleep onset

  Sleep recorded with a portable device

  Change from baseline sleep duration at treatment day 15

• Change in sleep efficiency

  Sleep recorded with a portable device

  Change from baseline sleep duration at treatment day 15

• Urinary 6-sulfatoxy-melatonin levels

  Urinary samples

  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)

  Change between treatment conditions in PSQI score at treatment day 15

• Nocturnal skin temperature

  Change between treatment conditions at bedtime at treatment days 14-15

Study Arms (2)

Melatonin

EXPERIMENTAL

2 mg oral tablet, melatonin slow release formulation, 1x 60 min before bedtime for 15 days

Drug: Melatonin

Placebo

PLACEBO COMPARATOR

2 mg oral tablet, 1x 60 min before bedtime for 15 days

Drug: Placebo

Interventions

Melatonin DRUG

2 Mg Oral Tablet, slow release

Melatonin

Placebo DRUG

placebo pill identical to the treatment pill

Placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Douglas Mental Health University Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Centre for Study and Treatment of Circadian Rhythms

Montreal, Quebec, J4J5L8, Canada

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Diane B Boivin, MD, PhD

  Douglas Hospital Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The nature of the treatment (melatonin vs placebo) will only be unrevealed when the key parameters have been determined (e.g, PSG sleep scoring, alertness levels, vasomotor symptoms, adverse effects, hormone levels).
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Centre for Study and Treatment of Circadian Rhythms

Model Details: Randomized crossover placebo-controlled study

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: July 1, 2022
• Study Start: June 17, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)