WithdrawnPhase 3

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

Stopped: Issues surrounding the current COVID-19 pandemic.

Canada0Started 2019-01-01

Plain-language 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.

Who can participate

Age range6 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Mean change in sleep onset latency (minutes)

Timeframe: Daily, up to 6 weeks

Trial details

NCT IDNCT02333149

SponsorUniversity of Alberta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-04

View on ClinicalTrials.gov More Attention Deficit/Hyperactivity Disorder trials