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Hormone Therapy

Melatonin for Traumatic Brain Injury

Phase 2

Recruiting

Research Sponsored by Children's National Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days post emergency department visit

Awards & highlights

Study Summary

This trial will test if giving melatonin to children after a concussion can help them sleep better, reduce depression, lower the risk of long-lasting concussion symptoms, and speed up their recovery.

Who is the study for?

This trial is for children and teenagers aged between 8 and 19 who have been diagnosed with an acute concussion within the last 72 hours. It's not specified, but typically people are excluded if they have other health issues that could interfere with the study or if they're already taking medications that might affect the outcome.Check my eligibility

What is being tested?

The trial is testing whether melatonin can help improve sleep, reduce depressive symptoms, lower the risk of long-term concussion effects, and speed up recovery after a concussion compared to a placebo (a pill without any active drug).See study design

What are the potential side effects?

Melatonin is generally considered safe but can cause side effects like drowsiness, headache, dizziness or nausea. Since it's used here for concussions in young people, parents should watch out for any unusual changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days post emergency department visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days post emergency department visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days post emergency department visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Brain Concussion

Secondary outcome measures

Brain Concussion

Time to resolution of concussion symptoms between melatonin and placebo post acute pediatric concussion

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: MelatoninActive Control1 Intervention

Liquid Melatonin

Group II: PlaceboPlacebo Group1 Intervention

Liquid Placebo

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Children's National Research InstituteLead Sponsor

211 Previous Clinical Trials

207,903 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA granted approval for the use of melatonin?

"Based on our assessment at Power, the safety of melatonin in this Phase 2 trial is rated as a 2. Although there is some evidence supporting its safety, there is currently no data indicating its efficacy."

Answered by AI

Is the study enrolling individuals aged 75 years and above?

"Individuals aged between 12 and 18 are eligible for participation in this research study. Notably, there exist a total of 47 trials catering to the younger demographic and another 51 focusing on participants over the age of 65."

Answered by AI

Is it feasible for me to be a participant in this clinical investigation?

"The research is currently enrolling 254 individuals aged between 12 and 18 who have experienced traumatic brain injury. Essential criteria include a recent diagnosis of acute concussion within the last 72 hours, with patients falling in the age range of over 8 but under 19 years old."

Answered by AI

What is the current number of participants enrolled in this clinical research study?

"Indeed, as shown on clinicaltrials.gov, this ongoing medical investigation is actively seeking participants. Originally listed on March 1st, 2023 and most recently revised on February 5th, 2024. The trial aims to enroll a total of 254 patients at a single designated site."

Answered by AI

Is the current investigation open for participant enrollment?

"Indeed, as stated on clinicaltrials.gov, this research trial is actively pursuing suitable candidates. The initial posting was made on March 1st, 2023 and the most recent revision occurred on February 5th, 2024. A total of 254 participants are sought at a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Acute Concussion and Melatonin

Jeremy Root 2023. "Acute Concussion and Melatonin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04731974.

All > Concussion > Melatonin