Evaluation of Continuous Symptom Treatment of ADHD

• Status: Completed
• Trial end date: 2004-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test the hypothesis that atomoxetine administered orally, once a day, at doses up to 1.4 mg/kg/day for approximately 6 weeks given in the morning is superior to placebo in children with ADHD.

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Atomoxetine Hydrochloride

Criteria

Inclusion Criteria:

• Patients must have ADHD that meets disease diagnostic criteria as defined by DSM-IV-Revised

• Males or females who are at least 6 years old and no more than 12 years old prior to visit 2

• Patients must be able to swallow capsules

• Patients must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as being without evidence of significant general intellectual deficit and expected to achieve a score of 70 or more if formal IQ testing were administered.

• Laboratory results must show no significant abnormalities (significance is defined as laboratory values requiring acute medical intervention, indicating a serious medical illness, or requiring further medical evaluation in the judgment of the investigator)

Exclusion Criteria:

• Patients who weigh less than 20 kg or greater than 65 kg at study entry (visit 1)

• Patients who have a documented history of bipolar I or bipolar II disorder, or psychosis

• Patients who have documented autism, Asperger's syndrome, or pervasive developmental disorder.

• Other comorbid psychiatric disorders are not excluded provided that the diagnosis of ADHD predates the comorbid disorder, and that the ADHD symptoms are the primary source of impairment for the patient

• Patients taking any antipsychotic medication during the 4 weeks prior to visit 1 are not eligible.