Melatonin Adolescent Research Study (MARS)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Sleep Disorders in Children
• Intervention / Treatment: Dietary supplement: Melatonin; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brooke Iwamoto; Phone Number: 909-558-7412; Email: biwamoto@llu.edu

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Not yet recruiting
      • Loma Linda University
      • Contact: Tori Van Dyk, PhD; Phone Number: 909-558-7412; Email: tvandyk@llu.edu
    • Loma Linda, California, United States, 92354
      • Recruiting
      • Loma Linda U
      • Contact: georgia Hodgkin, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 15 years (Child)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Administration of Placebo	Other: Placebo; Each subject will receive a placebo 1 hour prior to bedtime for 12 consecutive nights
Experimental: Administration of Melatonin	Dietary supplement: Melatonin; Each subject will receive 3mg of melatonin 1 hour prior to bedtime for 12 consecutive nights

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Objective Sleep Duration During Melatonin Administration	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	Change between baseline and two weeks
Change in Objective Sleep Duration During Placebo Administration	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	Change between baseline and two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Emotion Regulation During Melatonin Administration as Evidenced by the Emotion Regulation Index for Children and Adolescents (ERICA)	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.	Change between baseline and two weeks
Change in Emotion Regulation During Placebo Administration as Evidenced by the Emotion Regulation Index for Children and Adolescents (ERICA)	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.	Change between baseline and two weeks

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Tori Van Dyk, PhD, Loma Linda University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Adolescents; Melatonin; Sleep Disturbance; Daytime Functioning
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: 5200334

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No