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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000211-80-DK

Enrollment

Registered

2019-06-20

Start date

2019-08-26

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Product Name: Melatonin Pharmaceutical Form: Tablet INN or Proposed INN: Melatonin CAS Number: 73-31-4 Other descriptive name: MELATONIN

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Children ages 6-12 years diagnosed with Attention Deficit/Hyperactivity disorder ond verified sleep problems is included 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. ; 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. The effect is to be evaluated after 1 month, 3 months and 6 months. ; Primary end point(s): Primary endpoint: effect on Sleep onset latenty ;Timepoint(s) of evaluation of this end point: All endpoint will be evaluated before start after 1, 3 and 6 month	—

Measure

Time frame

Main Objective: Children ages 6-12 years diagnosed with Attention Deficit/Hyperactivity disorder ond verified sleep problems is included 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. ; 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. The effect is to be evaluated after 1 month, 3 months and 6 months. ; Primary end point(s): Primary endpoint: effect on Sleep onset latenty ;Timepoint(s) of evaluation of this end point: All endpoint will be evaluated before start after 1, 3 and 6 month

—

Secondary

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

Countries

Denmark

Contacts

Public ContactClinical Trial Information

Child and Adolescent psychiatri South Denmark

allan.hvolby@rsyd.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026