CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 8 enrolled
Drug / intervention
Melatonin +1 moredrug
Likely dose
Melatonin 40mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00867451
NCT00867451Phase 2Completed

A Pilot Study Designed To Improve Sleep and Subsequent Daytime Functioning in Children Diagnosed With ADHD

Children's Hospital Medical Center, Cincinnati·interventional·Posted Mar 23, 2009·Updated Mar 16, 2012

In Brief

A Phase 2 clinical trial evaluating Sleep Intervention and Melatonin for Attention Deficit Hyperactivity Disorder. Completed, enrolled 8 participants across 1 site.

Detailed Summary

This study will test the efficacy of a systematic, multi-modal intervention protocol designed to improve sleep functioning and subsequent alleviation of daytime cognitive and behavioral difficulties among children diagnosed with ADHD. It is hypothesized that children receiving behavioral and (if necessary) pharmacologic interventions targeting sleep will display improvement on objective and subjective sleep measures, neuropsychological tests, and teacher-, and parent-ratings of ADHD behaviors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 23, 2009
Enrollment StartJan 1, 2010
Primary CompletionJun 1, 2011
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.3 years ago

Interventions

Sleep Interventionbehavioral

A structured sleep protocol is taught to parents, use of a white noise generator

Melatonindrug

Body Weight \<40mg will be given 3mg at bedtime for two weeks Body Weight \>40mg will be given 6 mg at bedtime for two weeks