Comparison of Atomoxetine and Placebo in Children and Adolescents With ADHD and ODD

A Randomized, Double-Blind Comparison of Atomoxetine Hydrochloride and Placebo in Child and Adolescent Outpatients With Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder

The purpose of this trial is to test the effectiveness of atomoxetine in treating symptoms of ODD in children with ADHD and ODD.

Inclusion Criteria:

• Patients are male or female outpatients who are at least 6 years of age and not more than 12 years of age at study entry.
• Patients must meet DSM-IV diagnostic criteria for ADHD and ODD.
• If other comorbid conditions are present, either the ADHD or the ODD diagnosis must be the patient's primary diagnosis.
• Patients must have laboratory results, including serum chemistries, hematology, and urinalysis showing no significant abnormalities.
• Patients must have an ECG performed at study entry that is absent of any abnormality that, in the opinion of the physician, should exclude the patient.

Exclusion Criteria:

• Patients who weigh less than 20 kg or greater than 60 kg at study entry.
• Patients who have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder.
• Patients who have a current diagnosis of Major Depressive Disorder ([MDD]; with or without psychotic features), PTSD, or CDRS-R total raw score >40 at study entry.
• Patients with a history of any seizure disorder.
• Patients determined by the investigator to be at serious suicidal risk.