Using melatonin to improve recovery from pediatric concussions
The Effectiveness of Melatonin for the Treatment of Acute Pediatric Concussion
PHASE2 · Children's National Research Institute · NCT04731974
This study is testing if melatonin can help kids aged 12-18 recover better from concussions by improving their sleep and reducing lingering symptoms.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 254 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | Children's National Research Institute (other) |
| Locations | 1 site (Washington, District of Columbia) |
| Trial ID | NCT04731974 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of melatonin compared to a placebo in pediatric patients diagnosed with acute concussions. It is a randomized, single-blinded trial involving participants aged 12-18 who will wear actigraphy watches to monitor their sleep and activity patterns. Over a month, participants will take either melatonin or a placebo nightly and undergo weekly assessments to evaluate their concussion symptoms, sleep quality, and depressive symptoms. The goal is to determine if melatonin can reduce the risk of persistent post-concussive symptoms in these patients.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 12-18 who have been diagnosed with an acute concussion within the last 72 hours.
Not a fit: Patients with cognitive delays, those currently taking psychiatric medications, or those with severe head injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery outcomes for children suffering from concussions.
How similar studies have performed: While the use of melatonin for sleep issues is well-documented, this specific application for pediatric concussion recovery is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Washington, District of Columbia
- Children's National Hospital — Washington, District of Columbia, United States (RECRUITING)
Study contacts
- Study coordinator: Jeremy M Root, MD
- Email: jroot@childrensnational.org
- Phone: 703-407-6738
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Concussion, Mild, Concussion, Brain, Pediatric ALL