Clinical trial · Interventional
Acute Concussion and Melatonin
The Effectiveness of Melatonin for the Treatment of Acute Pediatric Concussion
NCT04731974CI-TRIAL-00073795unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Concussion, Brain | — | UNRESOLVED | — |
| Concussion, Mild | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Melatonin 3 MG | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Liquid Placebo
- interventionNames
- Other: Placebo
- type
- ACTIVE_COMPARATOR
- label
- Melatonin
- description
- Liquid Melatonin
- interventionNames
- Drug: Melatonin 3 MG
Primary outcomes (3)
- measure
- Comparison of average daily sleep duration between melatonin and placebo post acute pediatric concussion
- timeFrame
- 28 days post Emergency Department visit
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDBarlow KM, Brooks BL, Esser MJ, Kirton A, Mikrogianakis A, Zemek RL, MacMaster FP, Nettel-Aguirre A, Yeates KO, Kirk V, Hutchison JS, Crawford S, Turley B, Cameron C, Hill MD, Samuel T, Buchhalter J, Richer L, Platt R, Boyd R, Dewey D. Efficacy of Melatonin in Children With Postconcussive Symptoms: A Randomized Clinical Trial. Pediatrics. 2020 Apr;145(4):e20192812. doi: 10.1542/peds.2019-2812. Epub 2020 Mar 26. PMID 32217739