NCT04731974

Acute Concussion and Melatonin

The Effectiveness of Melatonin for the Treatment of Acute Pediatric Concussion

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 254 (estimated)
• Sponsor: Children's National Research Institute · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Accepted

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).

Conditions

• Concussion, Mild
• Concussion, Brain
• Pediatric ALL

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2021-02-01
• Last updated: 2024-02-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study