20 Participants Needed

Melatonin for Stress

JA
AM
Overseen ByAnna Murvich

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether melatonin, a common sleep aid, can reduce physical symptoms like heart rate and skin temperature during stress. Participants will take either a melatonin tablet or a placebo (a pill with no active ingredients) before undergoing stress tests. The trial seeks individuals who can abstain from caffeine and alcohol for a short period before the test and do not have certain sleep disorders or serious health conditions.

As an unphased trial, this study offers participants the chance to contribute to understanding how melatonin might help manage stress symptoms.

Will I have to stop taking my current medications?

If you are currently using psychoactive, hypnotic, stimulant, or analgesic medications, beta blockers, or alpha blockers, you will need to stop taking them at least a month before joining the trial. Occasional use of non-narcotic pain relievers is allowed.

Is there any evidence suggesting that melatonin is likely to be safe for humans?

Research has shown that melatonin is usually safe for use. In studies comparing melatonin to a placebo (a pill with no active ingredient), both groups reported very few side effects, indicating that melatonin users did not experience more side effects than those taking the placebo.

Melatonin is sold over-the-counter for sleep problems, suggesting it is generally safe for most people. No known dangerous reactions or conditions need to be avoided with melatonin. However, as with any supplement, following the recommended dose and consulting a healthcare provider if there are any concerns is important.12345

Why are researchers excited about this trial?

Unlike the standard treatments for stress, such as cognitive-behavioral therapy and medications like SSRIs, melatonin offers a natural alternative derived from the hormone that regulates sleep. Researchers are excited about melatonin because it may address stress by improving sleep quality, which is often disrupted during stressful periods. Additionally, melatonin is non-addictive and has a well-known safety profile, making it an attractive option for those seeking a more natural approach to managing stress.

What evidence suggests that melatonin might be an effective treatment for stress?

Research has shown that melatonin can reduce oxidative stress, a harmful process linked to stress. Studies suggest that melatonin may help the body manage stress by protecting brain areas affected by it and reducing related damage. In animal studies, melatonin improved stress-related behaviors. This trial will test melatonin as an experimental treatment, with participants ingesting a 3mg melatonin tablet before stress reactivity assessment. Known for regulating sleep, this treatment may also aid in managing stress. Although more human research is needed, these findings suggest melatonin might help manage stress responses.678910

Are You a Good Fit for This Trial?

This trial is for individuals who experience stress and are interested in how melatonin might affect their body's response to it. Specific eligibility criteria details were not provided, so general health status and other factors would need to be confirmed with the study organizers.

Inclusion Criteria

I can avoid exercise, caffeine for 12 hours, and alcohol for 24 hours before the test.
BMI must be less than 30 kg/m2
I am between 18 and 70 years old.
See 1 more

Exclusion Criteria

Habitual smoking (6 or more cigarettes per week)
High obstructive sleep apnea diagnosis determined by STOP-BANG
History of meeting DSM-V criteria of major psychiatric disorder
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either melatonin or placebo prior to stress reactivity assessment

4 weeks
Multiple visits for stress reactivity assessments

Follow-up

Participants are monitored for cardiovascular and skin temperature responses to stress

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Melatonin
Trial Overview The study is testing if taking a 3 MG Melatonin tablet before a stressful event can change how the heart works and skin temperature compared to a placebo (a pill without active ingredients).
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Melatonin (3mg)Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor University

Lead Sponsor

Trials
65
Recruited
67,600+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/35331482/
Melatonin effectiveness in amelioration of oxidative stress ...Conclusion: Results of the current meta-analysis showed that melatonin supplementation had a significant impact on attenuating of oxidative stress and enhancing ...
Comprehensive review of melatonin as a promising ...This review discusses the major biological activities of melatonin, its metabolites as nutritional supplements, and its bioavailability in food sources.
Melatonin-related dysfunction in chronic restraint stress ...The study explored the melatonin-related mechanisms of stress-associated sleep disorders on a mouse model of chronic stress.
Melatonin alleviates chronic stress-induced hippocampal ...Melatonin improves chronic stress-induced hippocampal damage and depression-like behaviors, but the mechanism needs further study.
Melatonin and DNA Integrity: The Impact of Exogenous ...MLT (N-acetyl-5-methoxytryptamine) has emerged as a compound of significant interest in mitigating exercise-induced oxidative stress and its consequences.
SAFETY DATA SHEET MelatoninPossibility of hazardous reactions No potentially hazardous reactions known. Conditions to avoid There are no known conditions that are likely ...
Current Insights into the Risks of Using Melatonin as a ...In the analysis of safety data from randomized, placebo-controlled trials, minimal adverse effects were reported with both melatonin and placebo ...
Melatonin SDS, 73-31-4 Safety Data SheetsAvoid dust formation. Avoid breathing mist, gas or vapours.Avoid contacting with skin and eye. Use personal protective equipment.Wear chemical impermeable ...
MelatoninThe (M)SDS is a Hazard Communication tool and should be used to assist in the Risk Assessment. Many factors determine whether the reported Hazards are Risks in ...
MelatoninLong-term exposure to the product is not thought to produce chronic effects adverse to the health (as classified by EC Directives using animal ...
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