Comparing Treatment With Melatonin to Treatment With Stimulants (Methylphenidate) in Children With Attention Deficit Hyperactivity Disorder and Sleep Difficulties

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01393574

Enrollment

Registered

2011-07-13

Start date

2011-06-30

Completion date

Unknown

Last updated

2011-07-13

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

Conditions

Attention Deficit Hyperactivity Disorder, Sleep Onset Insomnia

Brief summary

The study hypothesis is that some children with Attention-Deficit-Hyperactivity-Disorder (ADHD) who also have sleep onset difficulties will improve with Melatonin treatment to an extent similar to that of stimulants treatment. In order to check this hypothesis children with a new ADHD diagnosis who also have sleep difficulties will be treated with either Melatonin or with stimulants (Methylphenidate) for one month. The main outcome will be improvement of the ADHD symptoms.

Interventions

DRUGMelatonin

3 mg for body weight \<40kg, 6 mg for body weight \>40kg, once a day 30-60 minutes before sleep

DRUGMethylphenidate

Drug formulary and dose will be decided by the treating neurologist from the available options in Israel (as would be given if not participating in the trial)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

Healthy volunteers

Inclusion criteria

* children 6-18 years old with a new ADHD diagnosis who are candidates for treatment with stimulants * Also they suffer from sleep onset insomnia or difficult awakening

Exclusion criteria

* Drug treatment for ADHD or for sleep problems in the last 6 months * Any other chronic medical treatment * Sleep disorder requiring a different treatment * Asthma in the last 2 years

Design outcomes

Primary

Measure	Time frame	Description
ADHD symptoms improvement	a month	ADHD symptoms improvement - a clinical judgement based on history from the patient and parents, and from the teacher report

Secondary

Measure	Time frame	Description
Sleep difficulties improvement	1 month	Sleep difficulties improvement - clinical judgement based on history from the patient and parents and from a sleep diary.

Countries

Israel

Contacts

Primary ContactAmir Ytzhak, Dr.

omnebene@gmail.com972-8-9779944

Backup ContactAmir Livne, Dr.

livnea@asaf.health.gov.il972-8-9779944

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026