Acute Concussion and Melatonin

The Effectiveness of Melatonin for the Treatment of Acute Pediatric Concussion

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric ALL; Concussion, Mild; Concussion, Brain
• Intervention / Treatment: Other: Placebo; Drug: Melatonin 3 MG

Detailed Description

To compare the risk of persistent post-concussive symptoms (PPCS) between melatonin and placebo after an acute pediatric concussion.

To determine if melatonin compared to placebo reduces the risk of PPCS for pediatric patients.

This is a prospective single-blinded randomized control trial of pediatric patients in the emergency department (ED) diagnosed with an acute concussion. Patients 12-18 years old with an acute concussion diagnosis will be eligible. All participants will receive actigraphy watches to wear on their wrists and measure sleep and activity patterns. Participants in the melatonin group will be instructed to take 3 mg of liquid melatonin 1 hour prior to their habitual fall asleep time daily for 30 days. Participants in the placebo group will be instructed to take their placebo liquid 1/2 hour prior to their habitual fall asleep time daily for 30 days.

All participants will be given standardized weekly assessments to track their concussion, sleep and depressive symptoms for one month. Research assistants will also arrange follow up in the telemedicine neurology headache clinic within 4 weeks post injury. At the follow-up visit, subjects will complete the Post Concussion Symptom Inventory (PCSI), Pediatric Sleep Disturbance (PSD), and Revised Childhood Anxiety and Depression Scales (RCADS).

• Study Type: Interventional
• Enrollment (Estimated): 254
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jeremy M Root, MD; Phone Number: 703-407-6738; Email: jroot@childrensnational.org
• Study Contact Backup: Name: Bobbe Thomas, BA; Phone Number: 202-222-8775; Email: tbthomas@childrensnational.org

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Recruiting
      • Children's National Hospital
      • Contact: Jeremy M Root, MD; Email: jroot@cnmc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Liquid Placebo	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.
Active Comparator: Melatonin; Liquid Melatonin	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of persistent post-concussive symptoms between melatonin and placebo post acute pediatric concussion	It is hypothesized that subjects managed with melatonin post an acute concussion will have a decreased relative risk of PPCS compared to those managed with placebo	28 days post Emergency Department visit
Time to resolution of concussion symptoms between melatonin and placebo post acute pediatric concussion	It is hypothesized that subjects managed with melatonin post an acute concussion will have a decreased time to resolution of concussion symptoms compared to those managed with placebo	28 days post Emergency Department visit

Collaborators and Investigators

• Sponsor: Children's National Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): February 1, 2021

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: Pro00015567

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No