Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder Read More

Inclusion Criteria:

• Must sign informed consent.
• Male or female 6-12 years old.
• Negative pregnancy test.
• Meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition - Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD.
• No co-morbid illness that could affect safety, tolerability or interfere with participation.
• Blood pressure (BP) within the 95th percentile for age, gender, and height.
• Willing and able to comply with all the requirements defined in protocol.

Exclusion Criteria:

• Current controlled (requiring a restricted medication) or uncontrolled co-morbid psychiatric diagnosis (except Oppositional Defiant Disorder [ODD]).
• At risk for suicidal or violent behavior towards self or others.
• History of a suicide attempt.
• History of a structural cardiac abnormality or other serious cardiac problems.
• Non-responder to psychostimulant treatment.
• Is overweight.
• Seizures during the last 2 years (exclusive of infantile febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
• Has Conduct Disorder.
• Known history of alcohol or other substance abuse within the last 6 months.
• Any abnormal thyroid function.
• A concurrent chronic or acute illness, disability, or other condition that might confound results of safety assessments.
• Has had treatment with any known liver altering agents within 30 days prior to Screening.
• Taking any excluded medication.
• Previous use of DAYTRANA.
• Taking other medications that have Central Nervous System (CNS) effects.
• Female subject is pregnant or lactating.
• Has any skin disease, or history of any chronic skin disease, skin cancer, skin manifestations of allergic disease, or other dermatologic conditions.
• Has sensitive-skin syndrome or has sensitivities to the ingredients in soaps, lotions, cosmetics or adhesives.
• Has clinical signs and symptoms of skin irritation or hyper/hypopigmentation at the potential application sites.
• A documented allergy, hypersensitivity or intolerance of methylphenidate (MPH) or any components found in DAYTRANA.