Status:
UNKNOWN
PLAY GAME: Post-concussion Syndrome in Youth - Assessing the GABAergic Effects of Melatonin
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Children's Hospital of Eastern Ontario
Conditions:
Post-concussion Syndrome
Post-concussive Symptoms
Eligibility:
All Genders
8-19 years
Phase:
PHASE2
PHASE3
Brief Summary
PURPOSE: The long-term goal of this line of research is to develop rational, biologically based evidence for the treatment of post-concussion syndrome (PCS) in children. The objective of this applicat...
Detailed Description
We hypothesize that the treatment of children with PCS following mTBI with 3mg or 10mg of Melatonin for 28 days will result in a decrease in PCS symptoms as compared with placebo. Primary research qu...
Eligibility Criteria
Inclusion
- Concussion/mild traumatic brain injury trauma with an increase in symptoms (increase in PCS symptoms compared with pre-injury status) at 30 days post injury
- must be able to swallow pills
Exclusion
- Previous significant medical history, or previous concussion within 3 months
- Participant in a natural history study of concussion
- Lactose intolerance, as the placebo contains lactose
- Use of drugs that are likely to affect TMS, fMRI and/or sleep
- Inability to complete questionnaires/evaluation e.g. non-English language
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT01874847
Start Date
September 1 2013
End Date
September 1 2019
Last Update
April 18 2017
Active Locations (1)
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1
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B6A8