Acute Concussion and Melatonin

Pediatric ALL Clinical Trial

Official title:

The Effectiveness of Melatonin for the Treatment of Acute Pediatric Concussion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04731974
• Other study ID #: Pro00015567
• Status: Recruiting
• Phase: Phase 2
• Start date: March 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: Children's National Research Institute
• Contact: Jeremy M Root, MD
• Phone: 703-407-6738
• Email: jroot[@]childrensnational.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 254
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Brain
• Concussion, Mild
• Pediatric ALL

Intervention

Drug:
• Melatonin 3 MG
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.

Other:
• Placebo
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.

Locations

Country	Name	City	State
United States	Children's National Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Children's National Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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