Comparison of Atomoxetine Plus Either Comparator or Placebo in Children With ADHD Who Haven't Responded to Stimulant Therapy
Completed · Phase 3 · Has a placebo group
Conditions studied: Attention Deficit Hyperactivity Disorder
In brief
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.
Key facts
- Study ID
- NCT00485550
- Run by
- Eli Lilly and Company
- People needed
- 14
- Starts
- 2004-01-01
- Expected to finish
- 2005-03-01
- Last updated by the study team
- 2007-06-13
Who can join
Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. — Scottsdale, Arizona, United States
Full record on ClinicalTrials.gov
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