Clinical trial NCT04731974: Acute Concussion and Melatonin
Official title: The Effectiveness of Melatonin for the Treatment of Acute Pediatric Concussion
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Concussion, Mild
Concussion, Brain
Pediatric ALL
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 254
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective single blinded randomized control trial of pediatric patients in the emergency department (ED) diagnosed with an acute concussion.

Group A: melatonin Group B: routine/standard care
Primary purpose: TREATMENT

Brief 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).

Eligibility 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

Primary outcomes:
measure: Comparison of average daily sleep duration between melatonin and placebo post acute pediatric concussion
timeFrame: 28 days post Emergency Department visit
measure: Change in sleep quality between melatonin and placebo post acute pediatric concussion
timeFrame: 28 days post Emergency Department visit
measure: Change in depressive symptoms between melatonin and placebo post acute pediatric concussion
timeFrame: 28 days post Emergency Department visit
Secondary outcomes:
measure: Risk of persistent post-concussive symptoms between melatonin and placebo post acute pediatric concussion
timeFrame: 28 days post Emergency Department visit
measure: Time to resolution of concussion symptoms between melatonin and placebo post acute pediatric concussion
timeFrame: 28 days post Emergency Department visit
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
Study officials:
References:
citation: Barlow 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.