Acute Concussion and Melatonin

RECRUITING

I'm interested ...!!

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:

🦠 Concussion, Mild 🦠 Concussion, Brain 🦠 Pediatric ALL

🗓️ Study Start (Actual) 1 March 2023

🗓️ Primary Completion (Estimated) 30 June 2024

✅ Study Completion (Estimated) 30 June 2024

👥 Enrollment (Estimated) 254

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE2

Locations:

📍 Washington, District of Columbia, United States

📋 Eligibility Criteria

Description

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: 12 Years to 18 Years (CHILD, ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 20 January 2021
First Submitted that Met QC Criteria 28 January 2021
First Posted 1 February 2021

Study Record Updates

Last Update Submitted that Met QC Criteria 5 February 2024
Last Update Posted 7 February 2024
Last Verified February 2024