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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between baseline and two weeks
Awards & highlights

MARS Trial 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.Check my eligibility
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.See study design
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.

MARS Trial Eligibility Criteria

Inclusion Criteria

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

MARS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Objective Sleep Duration During Melatonin Administration
Change in Objective Sleep Duration During Placebo Administration
Secondary outcome measures
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

MARS 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
306 Previous Clinical Trials
260,904 Total Patients Enrolled
Tori Van Dyk, PhDPrincipal InvestigatorLoma Linda University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study still enrolling participants?

"The clinicaltrials.gov resource confirms that this trial is still searching for participants, with the initial post date having been on September 15th 2021 and the most recent update being logged on September 19th 2022."

Answered by AI

Could I be accepted into this research program?

"This investigation is inviting 80 youths between the ages of 13 and 17 with sleep disturbances to participate. Aspiring candidates must evidence self-reported sleeping issues, be able to comprehend English, not have taken melatonin beforehand, and meet all other requirements as detailed in the protocol."

Answered by AI

How many participants are taking part in this experiment?

"Affirmative. The requirements for this medical trial, which was introduced on September 15th 2021, are currently being sought after by the research team. They need 80 volunteers from 2 different sites to complete their study."

Answered by AI

Is this trial open to individuals aged 85 and above?

"The age range for eligibility in this clinical trial is 13 to 17 years old, as specified by the inclusion criteria."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Loma Linda U
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Melatonin Adolescent Research Study
2021. "Melatonin Adolescent Research Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04588233.
All > Melatonin
~15 spots leftby Dec 2024
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