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

University of Alberta

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Attention Deficit/Hyperactivity Disorder Initial Insomnia

Interventions

MelatoninDIETARY_SUPPLEMENT

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.

PlaceboDRUG

Placebo frequency and volume are identical to the experimental arm

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Alberta

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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