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

Phase 4

• Conditions: Attention Deficit Hyperactivity Disorder; Sleep Onset Insomnia
• Interventions: Drug: Melatonin; Drug: Methylphenidate

• Registration Number: NCT01393574
• Lead Sponsor: Assaf-Harofeh Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Status Verified: 2011-07
• Study First Submitted: 2011-07-12
• Study First Submitted QC: 2011-07-12
• Last Update Submitted: 2011-07-12
• Study First Posted: 2011-07-13
• Last Update Posted: 2011-07-13
• Primary Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin treatment	Melatonin	Treatment with Melatonin before sleep for 1 month - 3 mg for body weight \<40kg, 6mg for body weight \>40kg
Stimulants treatment	Methylphenidate	Treatment with Methylphenidate with a formulary and dose as decided by the treating neurologist, for 1 month.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Assaf Haroffeh Medical Center; 🇮🇱 Zeriffin, Israel