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NCT Number: NCT04588233

Melatonin Adolescent Research Study

The present study will use a within-person, randomized cross-over experimental design to test the effects of exogenous melatonin supplementation on the sleep and daytime functioning of typically developing adolescents with short or disrupted sleep of behavioral origins (i.e., difficulty falling asleep, staying asleep, or premature waking resulting in short or disrupted sleep not attributed to an organic sleep condition).

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Key information

Conditions

Sleep Disorders in Children Mental Disorders Nervous System Diseases Parasomnias Sleep Wake Disorders

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda U, Loma Linda, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Self-identified sleep difficulties (e.g., difficulty falling asleep, staying asleep, or premature waking resulting in short or disrupted sleep).
  • Ages 13 to 17 years old
  • Able to understand, read, and write in English
  • Melatonin naive

Exclusion criteria

  • Obesity
  • Use of psychiatric medication
  • Drug(s), or supplements known to affect sleep
  • History of head injury or concussion with loss of consciousness >1 minute
  • Daily consumption of >1 caffeinated beverage
  • Risk for any organic sleep disorder (e.g., obstructive sleep apnea, restless leg syndrome)

Treatment and study plan

melatonin

Dietary Supplement

Each subject will receive 3mg of melatonin 1 hour prior to bedtime for 12 consecutive nights

Placebo

Other

Each subject will receive a placebo 1 hour prior to bedtime for 12 consecutive nights

Primary outcomes

  1. Change in Objective Sleep Duration During Melatonin Administration

    Time frame: Change between baseline and two weeks

    Objective sleep will be measured via wrist-worn actigraphy worn nightly for 2 "run-in" nights followed by 12 consecutive nights after receiving melatonin (14 nights/2 weeks total). Changes in objective sleep duration would be demonstrated by either an increase or decrease in number of hours asleep compared to baseline

  2. Change in Objective Sleep Duration During Placebo Administration

    Time frame: Change between baseline and two weeks

    Objective sleep will be measured via wrist-worn actigraphy worn nightly for 2 "run-in" nights followed by 12 consecutive nights after receiving placebo (14 nights/2 weeks total). No change in objective sleep duration would be demonstrated compared to baseline

Secondary outcomes

  1. Change in Emotion Regulation During Melatonin Administration as Evidenced by the Emotion Regulation Index for Children and Adolescents (ERICA)

    Time frame: Change between baseline and two weeks

    The Emotion Regulation Index for Children and Adolescents (ERICA) is a 16-item adolescent-report measure with scores ranging from 16 to 80 (higher scores indicative of better emotion regulation). This measure will be administered during baseline and after 14 days (2 weeks) including a 2 day "run-in" followed by 12 days of melatonin administration. It is expected that emotion regulation will improve after melatonin administration compared to baseline. Normal emotion regulation varies by individual.

  2. Change in Emotion Regulation During Placebo Administration as Evidenced by the Emotion Regulation Index for Children and Adolescents (ERICA)

    Time frame: Change between baseline and two weeks

    The Emotion Regulation Index for Children and Adolescents (ERICA) is a 16-item adolescent-report measure with scores ranging from 16 to 80 (higher scores indicative of better emotion regulation). This measure will be administered during baseline and after 14 days (2 weeks) including a 2 day "run-in" followed by 12 days of placebo administration. It is expected that emotion regulation will remain the same after placebo administration compared to baseline. Normal emotion regulation varies by individual.

Study contacts

Contact information is provided by the study sponsor or research team.

Brooke Iwamoto

CONTACT

[email protected]

909-558-7412

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

Understanding the Impact of Melatonin Use on Adolescent Functioning: A Pilot and Feasibility Trial of the Melatonin Adolescent Research Study (MARS)

Acronym: MARS

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Oct 19, 2020
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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