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

Sponsor

University of Alberta (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02333149

Collaborator

The University of Queensland (Other)

Enrollment

Location

Arms

34.1

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

0 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 :

Jan 1, 2019

Actual Primary Completion Date :

Nov 4, 2021

Actual Study Completion Date :

Nov 4, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alberta	Edmonton	Alberta	Canada	T6G 1K8

Sponsors and Collaborators

University of Alberta
The University of Queensland

Investigators

Principal Investigator: Sunita Vohra, MD, University of Alberta

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Alberta

ClinicalTrials.gov Identifier:

NCT02333149

Other Study ID Numbers:

Pro00022025

First Posted:

Jan 7, 2015

Last Update Posted:

Nov 15, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Alberta

Melatonin

Additional relevant MeSH terms:

Hyperkinesis

Attention Deficit Disorder with Hyperactivity

Melatonin

Study Results

No Results Posted as of Nov 15, 2021