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Search / Trial NCT04318067

Melatonin in ADHD and Sleep Problems

Launched by ALLAN HVOLBY · Mar 20, 2020

Trial Information

Current as of October 12, 2025

Unknown status

Keywords

Melatonin Attention Deficit Hyperactivity Disorder Sleep Problems Dim Light Melatonin Onset

ClinConnect Summary

This clinical trial is studying how melatonin, a hormone that helps regulate sleep, can help children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) and sleep problems. Researchers want to find out if some children have a natural delay in releasing melatonin, which could affect how well melatonin treatment works for them. The goal is to better understand how melatonin functions in children with different psychiatric conditions and to see if there are differences in melatonin release between those with chronic sleep issues and those without.

Children aged 6 to 13 years who have been referred for ADHD treatment and have chronic sleep problems may be eligible to participate in this study. Participants will have their melatonin levels measured and will receive melatonin treatment, allowing researchers to gather important information about its effects. It’s important to note that children with certain conditions, such as autism or a low IQ, and those who have previously been treated with melatonin, cannot participate. This trial aims to improve understanding of sleep problems in children, which could lead to better treatment options in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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
  • Exclusion Criteria:
  • IQ below 70
  • Autism Disorder
  • Actual or former treated with Melatonin
  • Allergy to melatonin

About Allan Hvolby

Allan Hvolby is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and innovation. With a focus on developing groundbreaking therapies, Hvolby leads initiatives that prioritize patient safety and ethical standards while fostering collaboration among healthcare professionals, researchers, and regulatory bodies. His extensive experience in trial design and management enables the efficient execution of studies across various therapeutic areas, ensuring the delivery of high-quality data that supports informed decision-making in the medical community. Through a patient-centered approach, Allan Hvolby strives to contribute meaningful solutions that improve health outcomes and enhance quality of life.

Locations

Esbjerg, Denmark

Patients applied

0 patients applied

Trial Officials

Allan Hvolby, MD, Ph.D

Principal Investigator

Child and adolescent Psychiatric department, South Jutland

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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