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

NCT02333149 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2021-11-15

No results posted yet for this study

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.

Conditions

  • Attention Deficit/Hyperactivity Disorder
  • Initial Insomnia

Interventions

DIETARY_SUPPLEMENT

Melatonin

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.

DRUG

Placebo

Placebo frequency and volume are identical to the experimental arm

Sponsors & Collaborators

  • The University of Queensland

    collaborator OTHER

  • University of Alberta

    lead OTHER

Principal Investigators

  • Sunita Vohra, MD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2021-11-04
Completion
2021-11-04

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02333149 on ClinicalTrials.gov