Melatonin – production and release in children and adolescents with ADHD and chronic sleep problems

Phase 1

• Conditions: Attention Deficit Hyperactivity Disorder and Sleep Problems; MedDRA version: 21.1 Level: LLT Classification code 10003735 Term: Attention deficit-hyperactivity disorder System Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

• Registration Number: EUCTR2019-000211-80-DK
• Lead Sponsor: Child and adolescent Psychiatry, South Jutland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-20
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Children aged 6-12 years referred to the child and adolescent psychiatric department for examination/treatment for ADHD.
Diagnosed with ADHD (ICD-10)
Sleeping problems verified by Actigraphy

Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Ongoing treatment for sleep disturbances (melatonin, other sleep-regulating medication, weighted blankets) (all purposes)
Autisme
IQ below 70
allergy to melatonin

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: Children ages 6-12 years diagnosed with Attention Deficit/Hyperactivity disorder ond verified sleep problems is included<br> the objective is to evaluate the effect of melatonin on sleep in children aged 6-12 years with ADHD who have delayed melatonin release and normal melatonin release respectively.<br> <br> ;<br> Secondary Objective: to evaluate the effect of melatonin over time in children aged 6-12 years with ADHD who have delayed melatonin release and normal melatonin release respectively.<br> The effect is to be evaluated after 1 month, 3 months and 6 months.<br> ;<br> Primary end point(s): Primary endpoint: effect on Sleep onset latenty<br> <br> ;Timepoint(s) of evaluation of this end point: All endpoint will be evaluated before start after 1, 3 and 6 month

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Secondary endpoints<br> -Total Sleep Duration<br> -Number of awakenings<br> -Bedtime<br> -”Lights out”<br> -Sleep onset<br> -Time for awakening<br> -Quality of life<br> -ADHD-symptoms<br> -Side effects<br> <br> ;Timepoint(s) of evaluation of this end point: All endpoint will be evaluated before start after 1, 3 and 6 month