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

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ClinicalTrials.gov Identifier: NCT02333149
Recruitment Status : Active, not recruiting
First Posted : January 7, 2015
Last Update Posted : April 30, 2019
Sponsor:
Collaborator:
The University of Queensland
Information provided by (Responsible Party):
Sunita Vohra, 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.

Condition or disease Intervention/treatment Phase
Attention Deficit/Hyperactivity Disorder Initial Insomnia Dietary Supplement: Melatonin Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Melatonin in Youth: N-of-1 Trials in a Stimulant-treated Attention Deficit Hyperactivity Disorder (ADHD) Population
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: Melatonin
Dietary supplement: Melatonin 3 mg or 6 mg
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.


Placebo Comparator: Placebo
Drug: Placebo
Drug: Placebo
Placebo frequency and volume are identical to the experimental arm




Primary Outcome Measures :
  1. Mean change in sleep onset latency (minutes) [ Time Frame: Daily, up to 6 weeks ]
    The mean change in sleep onset latency will be measured using sleep diaries.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02333149


Locations
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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 1K8
Sponsors and Collaborators
University of Alberta
The University of Queensland
Investigators
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Principal Investigator: Sunita Vohra, MD University of Alberta

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sunita Vohra, Dr. Sunita Vohra, University of Alberta
ClinicalTrials.gov Identifier: NCT02333149     History of Changes
Other Study ID Numbers: Pro00022025
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sunita Vohra, University of Alberta:
Melatonin
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Nervous System Diseases
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Melatonin
Central Nervous System Stimulants
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants