NCT02333149

Melatonin in Youth: N-of-1 Trials in a Stimulant-treated Attention Deficit Hyperactivity Disorder (ADHD) Population

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Attention Deficit/Hyperactivity Disorder
• Initial Insomnia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Melatonin	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.
DRUG	Placebo	Placebo frequency and volume are identical to the experimental arm

Timeline

• Start date: 2019-01-01
• Primary completion: 2021-11-04
• Completion: 2021-11-04
• First posted: 2015-01-07
• Last updated: 2021-11-15

Locations

1 site across 1 country: Canada