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Hormone Therapy

Melatonin for Concussions

Phase 2
Recruiting
Research Sponsored by Children's National Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Must not have
Use of melatonin within the last week
Any patient with intracranial surgery, pathology or instrumentation (e.g. ventriculoperitoneal shunt, brain tumor etc)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days post emergency department visit
Awards & highlights

Summary

This trial will test if giving melatonin to children after a concussion can help them sleep better, reduce depression, lower the risk of long-lasting concussion symptoms, and speed up their recovery.

Who is the study for?
This trial is for children and teenagers aged between 8 and 19 who have been diagnosed with an acute concussion within the last 72 hours. It's not specified, but typically people are excluded if they have other health issues that could interfere with the study or if they're already taking medications that might affect the outcome.
What is being tested?
The trial is testing whether melatonin can help improve sleep, reduce depressive symptoms, lower the risk of long-term concussion effects, and speed up recovery after a concussion compared to a placebo (a pill without any active drug).
What are the potential side effects?
Melatonin is generally considered safe but can cause side effects like drowsiness, headache, dizziness or nausea. Since it's used here for concussions in young people, parents should watch out for any unusual changes.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have used melatonin in the past week.
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I have had brain surgery or have a brain-related health issue.
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I am currently on medication for a psychiatric condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days post emergency department visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days post emergency department visit 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 depressive symptoms between melatonin and placebo post acute pediatric concussion
Brain Concussion
Brain Concussion
Secondary study objectives
Brain Concussion
Time to resolution of concussion symptoms between melatonin and placebo post acute pediatric concussion

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: MelatoninActive Control1 Intervention
Liquid Melatonin
Group II: PlaceboPlacebo Group1 Intervention
Liquid Placebo

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Who is running the clinical trial?

Children's National Research InstituteLead Sponsor
218 Previous Clinical Trials
257,656 Total Patients Enrolled
~102 spots leftby Sep 2025
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