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

Shamir Medical Center (Assaf-Harofeh)

Status and phase: Unknown; Phase 4

Conditions: Attention Deficit Hyperactivity Disorder; Sleep Onset Insomnia

Treatments: Drug: Melatonin; Drug: Methylphenidate

Study type: Interventional

Funder types: Other

Identifiers

NCT01393574

83/11

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Melatonin treatment

Experimental group

Description:

Treatment with Melatonin before sleep for 1 month - 3 mg for body weight \<40kg, 6mg for body weight \>40kg

Treatment:

Drug: Melatonin

Stimulants treatment

Active Comparator group

Description:

Treatment with Methylphenidate with a formulary and dose as decided by the treating neurologist, for 1 month.

Treatment:

Drug: Methylphenidate