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

Primary Purpose

Attention Deficit/Hyperactivity Disorder, Initial Insomnia

Status
Withdrawn
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Melatonin
Placebo
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit/Hyperactivity Disorder focused on measuring Melatonin

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alberta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Melatonin

Placebo

Arm Description

Dietary supplement: Melatonin 3 mg or 6 mg

Drug: Placebo

Outcomes

Primary Outcome Measures

Mean change in sleep onset latency (minutes)
The mean change in sleep onset latency will be measured using sleep diaries.

Secondary Outcome Measures

Full Information

First Posted
December 16, 2014
Last Updated
November 5, 2021
Sponsor
University of Alberta
Collaborators
The University of Queensland
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1. Study Identification

Unique Protocol Identification Number
NCT02333149
Brief Title
Melatonin in Youth: N-of-1 Trials in a Stimulant-treated Attention Deficit Hyperactivity Disorder (ADHD) Population
Acronym
MYNAP
Official Title
Melatonin in Youth: N-of-1 Trials in a Stimulant-treated Attention Deficit Hyperactivity Disorder (ADHD) Population
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Issues surrounding the current COVID-19 pandemic.
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
November 4, 2021 (Actual)
Study Completion Date
November 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
The University of Queensland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit/Hyperactivity Disorder, Initial Insomnia
Keywords
Melatonin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Melatonin
Arm Type
Experimental
Arm Description
Dietary supplement: Melatonin 3 mg or 6 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Drug: Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Melatonin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo frequency and volume are identical to the experimental arm
Primary Outcome Measure Information:
Title
Mean change in sleep onset latency (minutes)
Description
The mean change in sleep onset latency will be measured using sleep diaries.
Time Frame
Daily, up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunita Vohra, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1K8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27473269
Citation
Punja S, Nikles CJ, Senior H, Mitchell G, Schmid CH, Heussler H, Witmans M, Vohra S. Melatonin in Youth: N-of-1 trials in a stimulant-treated ADHD Population (MYNAP): study protocol for a randomized controlled trial. Trials. 2016 Jul 29;17:375. doi: 10.1186/s13063-016-1499-6.
Results Reference
derived

Learn more about this trial

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

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