Melatonin lotion's effects on sleep and mental health
The Impact of Melatonin Lotion on Actigraphy, Sleep Quality, Autonomic Nervous System Indicators, Mood, Anxiety Symptoms, and Side Effects
This study is testing if using melatonin lotion can help young adults with sleep issues, depression, and anxiety feel better and sleep more soundly.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 21 Years |
| Sex | All |
| Sponsor | University of Redlands Academic / other |
| Locations | 1 site (Redlands, California) |
| Trial ID | NCT06768749 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are young adults with sleep disturbances and mild to moderate symptoms of anxiety or depression.
Not a fit: Patients currently using antidepressants, anti-anxiety medications, or sleep medications, including melatonin, may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Redlands, California
- University of Redlands — Redlands, California, United States (Recruiting)
Study contacts
- Principal investigator: Lisa E Olson, Ph.D. — University of Redlands
- Study coordinator: Lisa E Olson, Ph.D.
- Email: lisa_olson@redlands.edu
- Phone: 909-748-8524
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.