Recruiting
Phase 2

Melatonin

Sponsor:

Children's National Research Institute

Code:

NCT04731974

Conditions

Concussion, Mild

Concussion, Brain

Pediatric ALL

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Accepted

Interventions

Melatonin 3 MG

Placebo

Study Details

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.

Conditions

Concussion, Mild

Concussion, Brain

Pediatric ALL

Study ID

NCT04731974

Start date

Mar 1, 2023

Status verified date

Feb, 2024

Completion date

Jun 30, 2024

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Accepted

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

Study Design

Enrollment

254 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Liquid Placebo

active comparator: Melatonin

Liquid Melatonin

Interventions

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.

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.

Primary outcome measure

  • Comparison of average daily sleep duration between melatonin and placebo post acute pediatric concussion [ Time Frame: 28 days post Emergency Department visit ]
  • Change in sleep quality between melatonin and placebo post acute pediatric concussion [ Time Frame: 28 days post Emergency Department visit ]
  • Change in depressive symptoms between melatonin and placebo post acute pediatric concussion [ Time Frame: 28 days post Emergency Department visit ]

Central Contacts and Locations

Central contacts

Jeremy M Root, MD

703-407-6738jroot@childrensnational.org

Bobbe Thomas, BA

202-222-8775tbthomas@childrensnational.org

Locations

Children's National Hospital

Recruiting

Washington, District of Columbia, United States, 20010

Contacts

Jeremy M Root, MD

jroot@cnmc.org

More Information

Sponsor

Children's National Research Institute

Last update posted

Feb 7, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's National Research Institute on 2024-02-07.