Acute Concussion and Melatonin
The Effectiveness of Melatonin for the Treatment of Acute Pediatric Concussion
1 other identifier
interventional
254
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2023
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2021
CompletedFirst Posted
Study publicly available on registry
February 1, 2021
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedFebruary 7, 2024
February 1, 2024
1.3 years
January 20, 2021
February 5, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Comparison of average daily sleep duration between melatonin and placebo post acute pediatric concussion
It is hypothesized that subjects managed with melatonin post an acute concussion will have increased sleep duration compared to placebo
28 days post Emergency Department visit
Change in sleep quality between melatonin and placebo post acute pediatric concussion
It is hypothesized that subjects managed with melatonin post an acute concussion will have increased sleep quality compared to placebo
28 days post Emergency Department visit
Change in depressive symptoms between melatonin and placebo post acute pediatric concussion
It is hypothesized that subjects managed with melatonin post an acute concussion will have decreased depressive symptoms compared to placebo
28 days post Emergency Department visit
Secondary Outcomes (2)
Risk of persistent post-concussive symptoms between melatonin and placebo post acute pediatric concussion
28 days post Emergency Department visit
Time to resolution of concussion symptoms between melatonin and placebo post acute pediatric concussion
28 days post Emergency Department visit
Study Arms (2)
Placebo
PLACEBO COMPARATORLiquid Placebo
Melatonin
ACTIVE COMPARATORLiquid Melatonin
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patient diagnosed with an acute concussion within 72 hours
- Patient greater than 8 and less than 19 years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's National Hospital
Washington D.C., District of Columbia, 20010, United States
Related Publications (1)
Barlow KM, Brooks BL, Esser MJ, Kirton A, Mikrogianakis A, Zemek RL, MacMaster FP, Nettel-Aguirre A, Yeates KO, Kirk V, Hutchison JS, Crawford S, Turley B, Cameron C, Hill MD, Samuel T, Buchhalter J, Richer L, Platt R, Boyd R, Dewey D. Efficacy of Melatonin in Children With Postconcussive Symptoms: A Randomized Clinical Trial. Pediatrics. 2020 Apr;145(4):e20192812. doi: 10.1542/peds.2019-2812. Epub 2020 Mar 26.
PMID: 32217739BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics and Emergency Medicine, George Washington Univ School of Medicine
Study Record Dates
First Submitted
January 20, 2021
First Posted
February 1, 2021
Study Start
March 1, 2023
Primary Completion
June 30, 2024
Study Completion
June 30, 2024
Last Updated
February 7, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share
For the study, researchers will collect the age, sex, past medical history and through surveys, past, present and future symptoms after a head injury. This information will be used to determine which age groups are at risk and which constellation of symptoms persist following an acute head injury. All research documents and protected health information will be kept in a locked cabinet and a password protected RedCap database that only study staff personnel have access to. No data will be shared until manuscript is written, but will only be shared in manuscript and not in individual data. If significant adverse data is found for a patient, the Lead principal investigator will discuss with the subject and primary care physician.