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

University of Alberta

Status and phase: Withdrawn; Phase 3

Conditions: Attention Deficit/Hyperactivity Disorder; Initial Insomnia

Treatments: Dietary Supplement: Melatonin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02333149

Pro00022025

Details and patient eligibility

About

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.

Sex: All

Ages: 6 to 17 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Melatonin

Experimental group

Description:

Dietary supplement: Melatonin 3 mg or 6 mg

Treatment:

Dietary Supplement: Melatonin

Placebo

Placebo Comparator group

Description:

Drug: Placebo

Treatment:

Drug: Placebo