Recruiting

Melatonin Lotion

Sponsor:

University of Redlands

Code:

NCT06768749

Conditions

Sleep Problems

Depressive Disorder and Anxiety Disorders

Eligibility Criteria

Sex: All

Age: 18 - 21

Healthy Volunteers: Not accepted

Interventions

Melatonin lotion

Placebo lotion

Study Details

Brief summary:

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.

Conditions

Sleep Problems

Depressive Disorder and Anxiety Disorders

Study ID

NCT06768749

Start date

Feb 28, 2025

Status verified date

Apr, 2026

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • a T score ≥ 48 on the sleep disturbance short form Patient-Reported Outcomes Measurement Information System (PROMIS) measure, and
  • a T score ≥ 55 on the anxiety or depression short form PROMIS measures (mild symptoms or more)

Exclusion Criteria:

  • currently using antidepressant, anti-anxiety, or sleep medication including melatonin
  • are pregnant
  • have allergies/sensitivities to scented lotion
  • are unwilling to commit to keeping a similar bedtime (± 1 hour) during treatment weeks.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

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

Interventions

Melatonin lotion

3 g lotion applied one hour before bedtime

Placebo lotion

3 g of placebo lotion (scent-matched control) applied one hour before bedtime

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) ]
  • Anxiety [ Time Frame: Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total) ]
  • Depression [ Time Frame: Measured pre-treatment, at end of placebo week, and at end of active treatment week (3 weeks total) ]
  • Total sleep time [ Time Frame: Two weeks of data separated by a one week period ]
  • Sleep efficiency [ Time Frame: Two weeks of data separated by a one week period ]
  • Normalized high frequency power of heart rate variability [ Time Frame: Two weeks of data separated by a one week period ]
  • Anxiety by momentary ecological assessment [ Time Frame: Three times per day for two weeks of data separated by a one week period ]
  • Mood by momentary ecological assessment [ Time Frame: Three times per day for two weeks of data separated by a one week period ]
  • Salivary alpha-amylase [ Time Frame: Daily at bedtime for two weeks of data separated by a one week period ]

Central Contacts and Locations

Central contacts

Lisa E Olson, Ph.D.

909-748-8524lisa_olson@redlands.edu

Steven Moore, Ph.D.

(909) 748-8687steven_moore@redlands.edu

Locations

University of Redlands

Recruiting

Redlands, California, United States, 92374

Contacts

Lisa Olson, Ph.D.

909-748-8524lisa_olson@redlands.edu

Principal Investigator:

Lisa Olson, Ph.D.

More Information

Sponsor

University of Redlands

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • melatonin
  • sleep
  • heart rate variability
  • actigraphy
  • amylase
  • mood
  • anxiety
  • depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Redlands on 2026-05-01.