Safety and Efficacy of Switching From a Stimulant Medication to Atomoxetine in Children and Adolescents With ADHD
Completed · Phase 4
Conditions studied: Attention Deficit Hyperactivity Disorder
In brief
The purpose of this study is to assess changes in ADHD symptoms and tolerability of medication in children and adolescents switching from a stimulant to atomoxetine.
Key facts
- Study ID
- NCT00485875
- Run by
- Eli Lilly and Company
- People needed
- 62
- Starts
- 2004-06-01
- Expected to finish
- 2005-01-01
- Last updated by the study team
- 2007-06-13
Who can join
Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must be at least 6 years of age and not yet be 18 years of age at the completion of visit 6
- Patients must meet DSM-IV diagnostic criteria for ADHD (any subtype)
- Patients must have laboratory results showing no significant abnormalities (significant would include laboratory deviations requiring acute medical intervention or further medical evaluation)
- 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 a IQ test)
- Patients must be able to swallow capsules
You may not qualify if…
- Patients who weigh less than 22 kg or more than 70 kg at study entry
- Patients who have a history of Bipolar I or Bipolar II Disorder, psychosis, or a pervasive developmental disorder
- Patients with a history of any seizure disorder (other than febrile seizures) or prior EEG abnormalities related to epilepsy, 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
- Patients who have glaucoma
Where it is running
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-582-4559, 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. — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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