A Phase 3 interventional study of Melatonin and Placebo in Attention Deficit/Hyperactivity Disorder and Initial Insomnia, sponsored by University of Alberta. Withdrawn at 1 site in Canada. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-11-15.
Sponsored by University of Alberta · Phase 3, Interventional, and Treatment
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.
1,548 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 254 are open to participants now.
Browse Attention Deficit Disorder with Hyperactivity studies →University of Alberta is the lead sponsor of 819 studies on the registry; 166 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Exclusion Criteria:
Dietary supplement: Melatonin 3 mg or 6 mg
Dietary Supplement: Melatonin
Drug: Placebo
Drug: Placebo
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 frequency and volume are identical to the experimental arm
Mean change in sleep onset latency (minutes)
The mean change in sleep onset latency will be measured using sleep diaries.
Time frame: Daily, up to 6 weeks
This study is withdrawn, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Melatonin
Attention Deficit Disorder with Hyperactivity →