The Impact of Melatonin Lotion on Sleep and Mental Health

Part of paid clinical trials in Redlands, California.

Sponsor
University of Redlands
Study ID
NCT06768749
Status
Recruiting
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Conditions

  • Depressive Disorder and Anxiety Disorders
  • Sleep Problems

Eligibility Criteria

Sex
ALL
Age
18 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Melatonin lotion — OTHER
    3 g lotion applied one hour before bedtime
  • Placebo lotion — OTHER
    3 g of placebo lotion (scent-matched control) applied one hour before bedtime

Study Details

The purpose of this study is to examine the effect that melatonin lotion has on sleep quality, the nervous system, and mental health. Melatonin is a hormone secreted by the brain that regulates sleep and might improve depression and anxiety symptoms. The goal is to determine whether melatonin in lotion form is an effective treatment for young adults with inadequate sleep and might improve mental health. Participants will fill out surveys, wear an actigraph (a wrist-worn device that measures sleep), wear a heart rate monitor (a strap worn around one's chest), and provide nightly saliva samples during treatment weeks. In one of the two treatment weeks, participants will receive a lotion that contains melatonin. During the other week they will receive a control treatment that will be lotion with no melatonin, and there will be a week in between with no treatment at all.

Key Dates

Start date
Feb 28, 2025
Status verified
Apr 2026
Primary completion
Apr 1, 2028
Completion
Apr 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Melatonin lotion first
    Participants will be randomized to one week of treatment with melatonin lotion, followed by a week washout, then one week of treatment with placebo lotion
  • Experimental: Placebo lotion first
    Participants will be randomized to one week of treatment with placebo lotion, followed by a week washout, then one week of treatment with melatonin lotion

Primary Outcome Measure

Sleep disturbance [ Time Frame: Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of RedlandsRedlandsCalifornia92374
Lisa Olson, Ph.D.
[email protected]
909-748-8524
Lisa Olson, Ph.D. (PRINCIPAL_INVESTIGATOR)

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University of Redlands· Redlands, CA

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