Acute Concussion and Melatonin

Phase 2

Recruiting

• Conditions: Pediatric ALL; Concussion, Brain; Concussion, Mild
• Interventions: Drug: Melatonin 3 MG; Other: Placebo

• Registration Number: NCT04731974
• Lead Sponsor: Children's National Research Institute

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.

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 Timeline

• Study First Submitted: 2021-01-20
• Study First Submitted QC: 2021-01-28
• Study First Posted: 2021-02-01
• Study Start: 2023-03-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 254

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin	Melatonin 3 MG	Liquid Melatonin
Placebo	Placebo	Liquid Placebo

Primary Outcome Measures

Name	Time	Method
Comparison of average daily sleep duration between melatonin and placebo post acute pediatric concussion	28 days post Emergency Department visit	It is hypothesized that subjects managed with melatonin post an acute concussion will have increased sleep duration compared to placebo
Change in sleep quality between melatonin and placebo post acute pediatric concussion	28 days post Emergency Department visit	It is hypothesized that subjects managed with melatonin post an acute concussion will have increased sleep quality compared to placebo
Change in depressive symptoms between melatonin and placebo post acute pediatric concussion	28 days post Emergency Department visit	It is hypothesized that subjects managed with melatonin post an acute concussion will have decreased depressive symptoms compared to placebo

Secondary Outcome Measures

Name	Time	Method
Risk of persistent post-concussive symptoms between melatonin and placebo post acute pediatric concussion	28 days post Emergency Department visit	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
Time to resolution of concussion symptoms between melatonin and placebo post acute pediatric concussion	28 days post Emergency Department visit	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

Trial Locations

Locations (1)

Children's National Hospital; 🇺🇸 Washington, District of Columbia, United States