Clinical trial

The Effectiveness of Melatonin for the Treatment of Acute Pediatric Concussion

NCT04731974

Name

Pro00015567

Description

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.

Trial arms

Trial start

2023-03-01

Estimated PCD

2024-06-30

Trial end

2024-06-30

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

Melatonin

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.

Arms:

Placebo

Size

254

Primary endpoint

Comparison of average daily sleep duration between melatonin and placebo post acute pediatric concussion

28 days post Emergency Department visit

Change in sleep quality between melatonin and placebo post acute pediatric concussion

28 days post Emergency Department visit

Change in depressive symptoms between melatonin and placebo post acute pediatric concussion

28 days post Emergency Department visit

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a prospective single blinded randomized control trial of pediatric patients in the emergency department (ED) diagnosed with an acute concussion.\n\nGroup A: melatonin Group B: routine/standard care', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 254, 'type': 'ESTIMATED'}}

Updated at

2024-02-07

1 organization

1 product

4 indications

Organization

Children's National Research Institute

Product

Indication

Indication

Indication

Indication

Pediatric Acute Lymphoblastic Leukemia