The Effectiveness of Melatonin for the Treatment of Acute Pediatric Concussion
Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 18
Healthy Volunteers: t
View:
• Patient diagnosed with an acute concussion within 72 hours
• Patient greater than 8 and less than 19 years old
Locations
United States
Washington, D.c.
Children's National Hospital
RECRUITING
Washington D.c.
Contact Information
Primary
Jeremy M Root, MD
jroot@childrensnational.org
703-407-6738
Backup
Bobbe Thomas, BA
tbthomas@childrensnational.org
202-222-8775
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2024-06-30
Participants
Target number of participants: 254
Treatments
Placebo_comparator: Placebo
Liquid Placebo
Active_comparator: Melatonin
Liquid Melatonin
Related Therapeutic Areas
Sponsors
Leads: Children's National Research Institute