At a glance
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Maintenance of Response After Open-Label Treatment With Atomoxetine Hydrochloride in Adult Outpatients With Attention-Deficit/Hyperactivity Disorder (ADHD): A Placebo-Controlled, Randomized Withdrawal Study
In Brief
A Phase 3 clinical trial evaluating atomoxetine hydrochloride and Placebo for Attention Deficit Hyperactivity Disorder. Completed, enrolled 2,017 participants across 56 sites in 12 countries.
Detailed Summary
LYDO is a multi-center study that will enroll approximately 1925 adult outpatients with Attention Deficit/Hyperactivity Disorder (ADHD). Patients will receive, under open label conditions, atomoxetine up to 100 mg/day during the acute, open-label part of the study. Those patients that meet the response criteria will continue the blind phase of the study up to a year. During that period, patients that respond to atomoxetine will be randomized to continue the treatment with atomoxetine or with placebo (neither the patients nor investigators know if patients receive atomoxetine or placebo).
Study Details
Timeline
Interventions
Oral 40-100 mg/day
Oral delivery of matching placebo