Community-based Study Comparing Extended-release Methylphenidate and Atomoxetine in Children With Attention-deficit Hyperactivity Disorder

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

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 evaluated by physicians and parents in a community setting.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
• Treatments: Atomoxetine Hydrochloride; Methylphenidate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.