Melatonin in ADHD and Sleep Problems | NCT04318067

Studies
Melatonin in ADHD and Sleep Problems

NCT04318067

Sponsor

Allan Hvolby

Status

Unknown status

Last Update Posted

May 9, 2022Actual

Enrollment

80Estimated

Phase

Phase 4

Conditions

Attention Deficit Hyperactivity Disorder
Sleep Disorder

Interventions

Melatonin 3 mg

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Apr 2024Estimated

Completion Date

Nov 2024Estimated

First Submitted Date

Feb 14, 2020

First Submission Date that Met QC Criteria

Mar 20, 2020

First Posted Date

Mar 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2022

Last Update Posted Date

May 9, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Allan Hvolby, Principal Investigator, MD, Ph.D, Region of Southern DenmarkSponsor-Investigator

Lead Sponsor

Allan HvolbyOTHER

Collaborators

Name	Class
Sygehus Lillebaelt	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Melatonin 3 mg	Drug	Melatonin 3 mg is given ones a day - at bedtimes for 6 month	Sleep problems i Attention Deficit Hyperactivity Disorder

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Attention Deficit Hyperactivity Disorder - Scale Score (ADHD-RS)	A Scale Score measuring ADHD symptoms on a 4 point Likert Scale (0-3) . 18 Question with a Total max score of 54, Total minimum Score is 0 . Higher score is more symptoms.	6 month
Weiss Functional Impairment Rating Scale (WFIRS)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

13 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Allan Hvolby, MD, Ph.D	Contact	0045 99447300		allan.hvolby@rsyd.dk

Overall Officials

Name	Affiliation	Role
Allan Hvolby, MD, Ph.D	Child and adolescent Psychiatric department, South Jutland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Child and Adolescent Psychiatric department	Recruiting	Esbjerg		6715	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity
D012893	Sleep Wake Disorders
D020447	Parasomnias

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008550	Melatonin

Ancestor Terms

ID	Term
D014363	Tryptamines
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided