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

NCT01393574 | Unknown Phase 4

• 1 other identifier: 83/11
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder; Sleep Onset Insomnia

Outcome Measures

Primary Outcomes (1)

• ADHD symptoms improvement

  ADHD symptoms improvement - a clinical judgement based on history from the patient and parents, and from the teacher report

  a month

Secondary Outcomes (1)

• Sleep difficulties improvement

  1 month

Study Arms (2)

Melatonin treatment

EXPERIMENTAL

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

Drug: Melatonin

Stimulants treatment

ACTIVE COMPARATOR

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

Drug: Methylphenidate

Interventions

Melatonin DRUG

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

Melatonin treatment

Methylphenidate DRUG

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)

Also known as: Ritalin, Ritalin SR, Ritalin LA, Concerta

Stimulants treatment

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Assaf Haroffeh Medical Center

Zeriffin, Israel

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Melatonin; Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Amir Ytzhak, Dr.

CONTACT

972-8-9779944; omnebene@gmail.com

Amir Livne, Dr.

CONTACT

972-8-9779944; livnea@asaf.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 12, 2011
• First Posted: July 13, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2012
• Last Updated: July 13, 2011

Record last verified: 2011-07

Locations

IL (1)