This trial is active, not recruiting.

Conditions attention deficit/hyperactivity disorder, initial insomnia
Treatments melatonin, placebo
Phase phase 3
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Dietary supplement: Melatonin 3 mg or 6 mg
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.
(Placebo Comparator)
Drug: Placebo
Placebo frequency and volume are identical to the experimental arm

Primary Outcomes

Mean change in sleep onset latency (minutes)
time frame: Daily, up to 6 weeks

Eligibility Criteria

Male or female participants from 6 years up to 17 years old.

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

Additional Information

Official title Melatonin in Youth: N-of-1 Trials in a Stimulant-treated Attention Deficit Hyperactivity Disorder (ADHD) Population
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Alberta.