Acute Concussion and Melatonin

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	12 Years - 18 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04731974
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Children's National Research Institute
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Concussion, Mild, Concussion, Brain, Pediatric ALL

Additional Details

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).

Arms & Interventions

Arms

Placebo Comparator: Placebo

Liquid Placebo

Active Comparator: Melatonin

Liquid Melatonin

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's National Hospital, Washington D.C. 4140963, District of Columbia 4138106

Status

Recruiting

Address

Children's National Hospital

Washington D.C. 4140963, District of Columbia 4138106, 20010

Site Contact

Jeremy M Root, MD

[email protected]

703-407-6738

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