A Pilot Study of Daytrana TM in Children With Autism Co-Morbid for Attention Deficit Hyperactivity Disorder (ADHD) Symptoms

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label study of the efficacy of Daytrana (methylphenidate transdermal system) for the treatment of attention and behavioral symptoms in children with Autism Spectrum Disorders. Twenty patients will be enrolled and treated with 10-30 mg of Daytrana for a total of eight weeks. Changes in core hyperactivity, impulsivity, and inattention symptoms, autism spectrum symptoms and functional outcomes will be assessed. Acceptability of the transdermal route of administration in this population will also be assessed.

The researchers hypothesize that Daytrana is a safe and effective medication for children with Autism Spectrum Disorders who have symptoms of inattention, hyperactivity and impulsivity.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oklahoma
• Collaborator: Mark L. Wolraich, M.D.
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• Between 6 and 11 years

• Autism Spectrum Disorder

• Attention Deficit Hyperactivity Disorder

• Stimulant medication-free at study entry

• No clinically significant abnormalities that preclude safe participation

• Sufficient developmental level (~3 yrs)

• Able to keep appointments

• Able to communicate effectively

• Teacher cooperation

Exclusion Criteria:

• Received an investigational medication in the previous 30 days

• Current medication treatment is effective and well-tolerated

• Medical conditions that affect patient safety

• MAOIs within one month

• Hypertension

• Bipolar disorder or psychosis

• Anticonvulsants

• Psychotropic medication or health food supplement

• Tourette Disorder

• Seizure disorder

• Neurological condition

• Structural heart disease