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Melatonin for Sleep Disorders in Adolescents (MARS Trial)

N/A
Recruiting
Led By Tori Van Dyk, PhD
Research Sponsored by Loma Linda University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Melatonin naive
Ages 13 to 17 years old
Must not have
Obesity
Drug(s), or supplements known to affect sleep
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between baseline and two weeks
Awards & highlights

Summary

This trial will test whether melatonin can help improve the sleep of adolescents with behavioral sleep disruptions.

Who is the study for?
This study is for typically developing teens aged 13-17 who have trouble sleeping, like difficulty falling or staying asleep, or waking up too early. They must be new to using melatonin and able to read and write in English. Teens drinking more than one caffeinated drink daily, at risk of sleep disorders (like apnea), obese, on psychiatric meds, taking sleep-affecting drugs/supplements, or with a serious head injury can't join.
What is being tested?
The trial is testing if melatonin supplements help improve sleep and daytime functioning in adolescents with self-reported sleep issues. Participants will receive either the melatonin supplement or a placebo without knowing which one they are taking during different periods of the study.
What are the potential side effects?
Melatonin may cause side effects such as morning grogginess, mood changes, headaches and dizziness. However, many people take it without any problems. The placebo should not cause any side effects since it doesn't contain active medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have never taken melatonin.
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I am between 13 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am considered obese.
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I am not taking any medications or supplements that affect my sleep.
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I am at risk for sleep disorders like sleep apnea or restless leg syndrome.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between baseline and two weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change between baseline and two weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Objective Sleep Duration During Melatonin Administration
Change in Objective Sleep Duration During Placebo Administration
Secondary study objectives
Melatonin
Change in Emotion Regulation During Placebo Administration as Evidenced by the Emotion Regulation Index for Children and Adolescents (ERICA)

Side effects data

From 2014 Phase 2 trial • 40 Patients • NCT01114373
42%
Fatigue
39%
Early Morning Wakening
36%
Daytime drowsiness
11%
Weakness
11%
Dizziness
11%
Nausea
11%
Blurred vision
100%
80%
60%
40%
20%
0%
Study treatment Arm
Melatonin
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Administration of MelatoninExperimental Treatment1 Intervention
Group II: Administration of PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melatonin
2014
Completed Phase 4
~1150

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor
312 Previous Clinical Trials
260,825 Total Patients Enrolled
Tori Van Dyk, PhDPrincipal InvestigatorLoma Linda University
~4 spots leftby Dec 2024
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