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

Attention Deficit/Hyperactivity Disorder Clinical Trial

— MYNAP  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02333149
• Other study ID #: Pro00022025
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 1, 2019
• Est. completion date: November 4, 2021

Study information

• Verified date: November 2021
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 4, 2021
• Est. primary completion date: November 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit/Hyperactivity Disorder
• Hyperkinesis
• Initial Insomnia

Intervention

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

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	The University of Queensland

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in sleep onset latency (minutes)	The mean change in sleep onset latency will be measured using sleep diaries.	Daily, up to 6 weeks