Melatonin in Youth: N-of-1 Trials in a Stimulant-treated Attention Deficit Hyperactivity Disorder (ADHD) Population
This trial is active, not recruiting.
|Conditions||attention deficit/hyperactivity disorder, initial insomnia|
|Sponsor||University of Alberta|
|Collaborator||The University of Queensland|
|Start date||December 2015|
|End date||December 2017|
|Trial size||300 participants|
|Trial identifier||NCT02333149, Pro00022025|
This study is a multi-center, randomized, triple-blind, placebo-controlled parallel-group trial, in which each participant is offered an N-of-1 trial. The purpose of this study is to assess the efficacy and safety of melatonin (3 mg or 6 mg) compared with placebo for initial insomnia in children with attention-deficit disorder.
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Mean change in sleep onset latency (minutes)
time frame: Daily, up to 6 weeks
Male or female participants from 6 years up to 17 years old.
- School-aged children and adolescents between the ages of 6 to 17 years
- Confirmed diagnosis of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- Co-morbid psychiatric/neurological diagnoses that may affect sleep
- Co-morbid seizure disorder
- Co-morbid sleep disorder
- Concurrent use of immunosuppressive drugs, blood pressure drugs, selective serotonin re-uptake inhibitors or anticoagulant drugs;
- Pregnancy or breastfeeding
|Official title||Melatonin in Youth: N-of-1 Trials in a Stimulant-treated Attention Deficit Hyperactivity Disorder (ADHD) Population|
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