Clinical trial Recruiting at 1 site Interventional Ages 18 to 21

Melatonin lotion's effects on sleep and mental health

Official title: The Impact of Melatonin Lotion on Actigraphy, Sleep Quality, Autonomic Nervous System Indicators, Mood, Anxiety Symptoms, and Side Effects

Run by University of Redlands · NCT06768749 · Data updated 2026-11-12

This study is testing if using melatonin lotion can help young adults with sleep issues, depression, and anxiety feel better and sleep more soundly.

More Sleep Problems trials

Quick facts

Study typeInterventional
Ages18 Years to 21 Years
SexAll
Enrollment60 (estimated)
SponsorUniversity of Redlands
Academic / other
Locations1 site (Redlands, California)
StatusRecruiting
StartedFebruary 28, 2025
Main results expectedApril 1, 2028
Study endsApril 1, 2028
Registry record updatedMay 1, 2026
Trial IDNCT06768749 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are young adults with sleep disturbances and mild to moderate symptoms of anxiety or depression.

Probably not a fit

Patients currently using antidepressants, anti-anxiety medications, or sleep medications, including melatonin, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study examines how melatonin lotion affects sleep quality and mental health in young adults experiencing sleep problems, depression, and anxiety. Participants will use melatonin lotion and a placebo lotion in a randomized crossover design, applying the lotion before bedtime for one week each. Throughout the study, they will wear devices to monitor sleep and heart rate, complete mood assessments, and provide saliva samples. The goal is to determine the effectiveness of melatonin lotion in improving sleep and mental health outcomes.

Why it matters

Potential benefit: If successful, this study could provide a novel topical treatment option for improving sleep quality and alleviating symptoms of depression and anxiety.

How similar studies have gone: While topical melatonin treatments are less common, other studies have shown positive effects of melatonin on sleep and mental health, suggesting potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • University of Redlands
    Redlands, California, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.