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

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.

Timeline

Start

2019-01-01

Primary completion

2021-11-04

Completion

2021-11-04

Publications

• Punja S, Nikles CJ, Senior H, Mitchell G, Schmid CH, Heussler H, Witmans M, Vohra S. Melatonin in Youth: N-of-1 trials in a stimulant-treated ADHD Population (MYNAP): study protocol for a randomized controlled trial. Trials. 2016 Jul 29;17:375. doi: 10.1186/s13063-016-1499-6.

Drugs

Indications