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The main purpose of the study is to help to understand the effect on children and adolescents who are stable on treatment with atomoxetine or osmotic-release oral system methylphenidate for Attention Deficit Hyperactivity Disorder(ADHD)of not taking the medication for a maximum of 6 days over a 28 day study treatment period.
The present study is designed to assess the effect of missed doses of daily medication (off-days). On the off-days the patient will take a placebo (sugar pill).Over the four weeks of the actual study there will be six random off-days of study medicine and neither the caregiver, patient nor study doctor will know which days are the missing days.
To cover all aspects of the patients' lives and notably their school time, aside from investigator's assessments, evaluations will also be performed on a daily basis by those involved in their day-to-day life: parents, teachers (on school days) and the patients themselves, using an electronic diary.
Allocation: Non-Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
Atomoxetine, Osmotic-release oral system methylphenidate, Placebo
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559)
Eli Lilly and Company
Published on BioPortfolio: 2014-08-27T03:13:32-0400
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