Melatonin in ADHD and Sleep Problems

NCT04318067 | Unknown Phase 4 DMC

• 1 other identifier: 18081070
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment with melatonin is often initiated on an insufficient basis as it has not been established prior to starting the treatment whether or not the child had delayed release of endogenous melatonin. At the clinic, it has furthermore been observed that the length of time a child experiences an effect of melatonin treatment varies substantially. In a clinical context, treatment with melatonin is used increasingly (www.Medstat.dk). However, there is no tradition in Denmark for measuring the endogenous melatonin level before initiating such treatment. Hence there is no way of knowing to what extent the sleep problems were indeed caused by delayed melatonin release. There seem to be no studies on the difference in the effect of melatonin treatment of children and adolescents depending on whether or not they have delayed DLMO. Likewise, there are no studies including adolescents. As can be seen, it is important to gain more knowledge about the normal release of melatonin, and the release of melatonin in a group of children and adolescents with a variety of psychiatric diagnoses. It is also essential to investigate whether there are any differences in the release of melatonin in children and adolescents with chronic sleep onset problem and children and adolescents who do not have sleep problems.

Conditions

Attention Deficit Hyperactivity Disorder; Sleep Disorder

Keywords

Melatonin; Attention Deficit Hyperactivity Disorder; Sleep problems; Dim Light Melatonin Onset

Outcome Measures

Primary Outcomes (3)

• Sleep onset Latency (SOL)

  How long time does the child use falling asleep after lights out

  6 month

• Sleep onset

  Time where child falls asleep

  6 month

• Total Sleep time

  6 month

Secondary Outcomes (4)

• Attention Deficit Hyperactivity Disorder - Scale Score (ADHD-RS)

  6 month

• Weiss Functional Impairment Rating Scale (WFIRS)

  6 month

• Dundee Difficult Times of the Day Scale (D-DTODS)

  6 month

• Side effect Rating Scale

  6 month

Study Arms (1)

Sleep problems i Attention Deficit Hyperactivity Disorder

EXPERIMENTAL

Children age 6 to 12 years having ADHD and Sleeping problem will be treated with Melatonin 3 mg one a day (before bedtime)

Drug: Melatonin 3 mg

Interventions

Melatonin 3 mg DRUG

Melatonin 3 mg is given ones a day - at bedtimes for 6 month

Sleep problems i Attention Deficit Hyperactivity Disorder

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6-13 years referred to the child and adolescent psychiatric department for examination/treatment for ADHD
• Verified Cronical Sleep Problems
• Measured Dim Light Melatonin Onset

You may not qualify if:

• IQ below 70
• Autism Disorder
• Actual or former treated with Melatonin
• Allergy to melatonin

Sponsors & Collaborators

• Allan Hvolby: lead
• Sygehus Lillebaelt: collaborator

Study Sites (1)

Child and Adolescent Psychiatric department

Esbjerg, 6715, Denmark

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Sleep Wake Disorders; Parasomnias

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Allan Hvolby, MD, Ph.D

  Child and adolescent Psychiatric department, South Jutland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allan Hvolby, MD, Ph.D

CONTACT

0045 99447300; allan.hvolby@rsyd.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, MD, Ph.D

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: March 23, 2020
• Study Start: September 1, 2020
• Primary Completion: April 1, 2024
• Study Completion: November 1, 2024
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)