Status:
COMPLETED
Community-based Study Comparing Extended-release Methylphenidate and Atomoxetine in Children With Attention-deficit Hyperactivity Disorder
Lead Sponsor:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-12 years
Phase:
PHASE4
Brief Summary
The purpose of this study was to better understand the treatment outcomes of extended-release methylphenidate and atomoxetine in children with attention-deficit hyperactivity disorder (ADHD) as evalua...
Detailed Description
Methylphenidate and atomoxetine are available for the treatment of ADHD in children. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and inc...
Eligibility Criteria
Inclusion
- Patients who met the DSM-IV criteria for a primary diagnosis of ADHD of any subtype (may have been newly diagnosed with ADHD and not on treatment)
- score of 24 or higher on the ADHD Rating Scale (ADHD-RS) at screening
- physician must have rated the patient as "Moderately ill" or worse on the CGI-S at screening
- children may have been enrolled who were not receiving adequate treatment for ADHD (based on clinical judgment in consultation with the parent)
- children must have been washed-out of their current treatment a minimum of 3 days or 5 half lives of the medication whichever was longer
- and the child and parent must have given written informed consent, and assent, where applicable.
Exclusion
- Female child who had experienced menarche
- presence of eating or substance disorder or co-morbid psychiatric condition other than oppositional defiant disorder
- history of seizure, tic disorder, mental retardation, severe developmental disorder (i.e. severe cerebral palsy, autism) or family history of Tourette's Disorder
- required medications as excluded by the package inserts for Concerta or Strattera
- diagnosed with hyperthyroidism or glaucoma
- and known non-responders to treatments indicated for ADHD.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2003
Estimated Enrollment :
1323 Patients enrolled
Trial Details
Trial ID
NCT00866996
End Date
December 1 2003
Last Update
May 24 2011
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