Acute Concussion and Melatonin

Last updated: February 5, 2024
Sponsor: Children's National Research Institute
Overall Status: Active - Recruiting

Phase

2

Condition

Brain Injury

Treatment

Melatonin 3 MG

Placebo

Clinical Study ID

NCT04731974
Pro00015567
  • Ages 12-18
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient diagnosed with an acute concussion within 72 hours
  • Patient greater than 8 and less than 19 years old

Exclusion

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

Total Participants: 254
Treatment Group(s): 2
Primary Treatment: Melatonin 3 MG
Phase: 2
Study Start date:
March 01, 2023
Estimated Completion Date:
June 30, 2024

Study 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).

Connect with a study center

  • Children's National Hospital

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.