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Acute Concussion and Melatonin

RECRUITINGPhase 2Sponsored by Children's National Research Institute
Actively Recruiting
PhasePhase 2
SponsorChildren's National Research Institute
Started2023-03-01
Est. completion2024-06-30
Eligibility
Age12 Years – 18 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT04731974

Summary

In this study, the investigator plans a randomized trial of melatonin versus placebo post acute pediatric concussion. The investigator hypothesizes that patients with acute concussions managed with melatonin will have improved sleep, decreased depressive symptoms, decreased risk of prolonged concussion symptoms and faster resolution of concussion symptoms.

Eligibility

Age: 12 Years – 18 YearsHealthy volunteers accepted
Inclusion Criteria:

* Patient diagnosed with an acute concussion within 72 hours
* Patient greater than 8 and less than 19 years old

Exclusion Criteria:

* Currently taking psychiatric medication
* Cognitive delay
* Glasgow Coma Score \< 14
* positive findings on head computed tomography
* Any patient with intracranial surgery, pathology or instrumentation (e.g. ventriculoperitoneal shunt, brain tumor etc)
* Use of melatonin within the last week

Conditions4

CancerConcussion, BrainConcussion, MildPediatric ALL

Locations1 site

Children's National Hospital
Washington D.C., District of Columbia, 20010
Jeremy M Root, MDjroot@cnmc.org

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