The study is designed to investigate the acute treatment efficacy, safety, and tolerability of atomoxetine on a once-daily dosing strategy (in the morning). It incorporates a 6-week acute treatment period and a 2-week discontinuation phase. The assessments in this study include a standard assessment of ADHD symptomatology using a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition™, investigator-administered rating scale.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
105
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.
Moscow, Russia
Efficacy of atomoxetine administered as a single-daily dose with placebo in Russian children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).
To compare improvement in symptoms associated with ADHD in children and adolescents achieved by once-daily dosing of atomoxetine or placebo, defined by a more than 25% reduction in the ADHDRS-IV-Parent:Inv total score and by mean reductions in Conners
To assess the safety and tolerability of once-daily dosing of atomoxetine in Russian children and adolescents
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