Acute Concussion and Melatonin

Study Overview
=================
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).

Official Title
-----------------
The Effectiveness of Melatonin for the Treatment of Acute Pediatric Concussion

Conditions
-----------------
Concussion, Mild, Concussion, Brain, Pediatric ALL

Intervention / Treatment
-----------------
* Drug: Melatonin 3 MG
* Other: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Liquid Placebo | Other: Placebo<br>* Participants in the placebo group will be instructed to take liquid placebo pill 1 hour prior to their habitual fall asleep time daily for 30 days.<br>|
| Active Comparator: Melatonin<br>Liquid Melatonin | Drug: Melatonin 3 MG<br>* Participants in the melatonin group will be instructed to take 3-mg liquid melatonin pill 1 hour prior to their habitual fall asleep time daily for 30 days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of average daily sleep duration between melatonin and placebo post acute pediatric concussion | It is hypothesized that subjects managed with melatonin post an acute concussion will have increased sleep duration compared to placebo | 28 days post Emergency Department visit | 
| Change in sleep quality between melatonin and placebo post acute pediatric concussion | It is hypothesized that subjects managed with melatonin post an acute concussion will have increased sleep quality compared to placebo | 28 days post Emergency Department visit | 
| Change in depressive symptoms between melatonin and placebo post acute pediatric concussion | It is hypothesized that subjects managed with melatonin post an acute concussion will have decreased depressive symptoms compared to placebo | 28 days post Emergency Department visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of persistent post-concussive symptoms between melatonin and placebo post acute pediatric concussion | It is hypothesized that subjects managed with melatonin post an acute concussion will have a decreased relative risk of PPCS compared to those managed with placebo | 28 days post Emergency Department visit | 
| Time to resolution of concussion symptoms between melatonin and placebo post acute pediatric concussion | It is hypothesized that subjects managed with melatonin post an acute concussion will have a decreased time to resolution of concussion symptoms compared to those managed with placebo | 28 days post Emergency Department visit |