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

Phase 3

Withdrawn

• Conditions: Attention Deficit/Hyperactivity Disorder; Initial Insomnia
• Interventions: Dietary Supplement: Melatonin; Drug: Placebo

• Registration Number: NCT02333149
• Lead Sponsor: University of Alberta

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-12-16
• Study First Submitted QC: 2015-01-05
• Study First Posted: 2015-01-07
• Study Start: 2019-01-01
• Status Verified: 2021-11
• Primary Completion: 2021-11-04
• Study Completion: 2021-11-04
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin	Melatonin	Dietary supplement: Melatonin 3 mg or 6 mg
Placebo	Placebo	Drug: Placebo

Primary Outcome Measures

Name	Time	Method
Mean change in sleep onset latency (minutes)	Daily, up to 6 weeks	The mean change in sleep onset latency will be measured using sleep diaries.

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada