Attention Deficit/Hyperactivity Disorder, Initial Insomnia
Conditions
Keywords
Melatonin
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTMelatonin
Children \<40 kg will take one tablet, melatonin 3 mg, oral, 30 - 60 minutes prior to bedtime. Children ≥40 kg will take two tablets, melatonin 3 mg, oral, 30-60 minutes prior to bedtime.
DRUGPlacebo
Placebo frequency and volume are identical to the experimental arm
Sponsors
The University of Queensland
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in sleep onset latency (minutes) | Daily, up to 6 weeks | The mean change in sleep onset latency will be measured using sleep diaries. |
Countries
Canada
Outcome results
None listed