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

NCT02333149 | Withdrawn Phase 3 DMC

• 1 other identifier: Pro00022025
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit/Hyperactivity Disorder; Initial Insomnia

Keywords

Melatonin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Melatonin

EXPERIMENTAL

Dietary supplement: Melatonin 3 mg or 6 mg

Dietary Supplement: Melatonin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Drug: Placebo

Interventions

Melatonin DIETARY_SUPPLEMENT

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.

Melatonin

Placebo DRUG

Placebo frequency and volume are identical to the experimental arm

Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• The University of Queensland: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 1K8, Canada

Location

Related Publications (1)

• 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.

  PMID: 27473269 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Sunita Vohra, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2014
• First Posted: January 7, 2015
• Study Start: January 1, 2019
• Primary Completion: November 4, 2021
• Study Completion: November 4, 2021
• Last Updated: November 15, 2021

Record last verified: 2021-11

Locations

CA (1)