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Acute Concussion and Melatonin

NCT04731974 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2024-02-07

No results posted yet for this study

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.

Conditions

  • Concussion, Mild
  • Concussion, Brain
  • Pediatric ALL

Interventions

DRUG

Melatonin 3 MG

Participants in the melatonin group will be instructed to take 3-mg liquid melatonin pill 1 hour prior to their habitual fall asleep time daily for 30 days.

OTHER

Placebo

Participants in the placebo group will be instructed to take liquid placebo pill 1 hour prior to their habitual fall asleep time daily for 30 days.

Sponsors & Collaborators

  • Children's National Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-06-30
Completion
2024-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04731974 on ClinicalTrials.gov