Comparison of Atomoxetine Plus Either Comparator or Placebo in Children With ADHD Who Haven't Responded to Stimulant Therapy

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and tolerability of atomoxetine alone versus atomoxetine plus low-dose, sustained-release MPH in children with treatment-resistant ADHD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Atomoxetine Hydrochloride; Central Nervous System Stimulants; Methylphenidate

Criteria

Inclusion Criteria:

• Patients will be at least 6 years of age and not more than 12 years of age at visit 1

• Patients must meet DSM-IV diagnostic criteria for ADHD

• Patients must be retrospectively identified as stimulant non-responders

• Patients must be of normal intelligence as assessed by the investigator (that is, without a general impairment of intelligence and likely, in the investigator's judgment, to achieve a score of greater than or equal to 70 on an IQ test)

• Patients must be able to swallow capsules

Exclusion Criteria:

• Patients who weigh less than 22 kg or more than 60 kg at study entry

• Patients who have a history of Bipolar I or Bipolar II Disorder, psychosis, or pervasive developmental disorder

• Patients who meet DSM-IV criteria for anxiety disorder or autism

• Patients with a history of any seizure disorder and/or Rolandic seizures (other than febrile seizures) or prior electroencephalogram (ECG) abnormalities in the absence of seizures, or patients who have taken (or are currently taking) anticonvulsants for seizure control

• Patients with a history of severe allergies to more than one class of medication or multiple adverse drug reactions, including hypersensitivity to MPH