Maintenance of Benefit With Atomoxetine Hydrochloride in Adolescents With ADHD

Phase 4CompletedNCT00191035

Eli Lilly and Company520 enrolled

Overview

The purpose of this study is to assess the efficacy, safety and tolerability of atomoxetine administered once daily in the treatment of adolescents with ADHD after 8 weeks and after 52 weeks

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

520

Conditions

Attention-Deficit/Hyperactivity Disorder

Interventions

AtomoxetineDRUG

Eligibility

Sex: ALLMin age: 13 YearsMax age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients must have ADHD. * Must be 13-16 years of age. * Must be able to swallow capsules. * Expected to achieve score of 70 or more on IQ test * Willing and reliable to keep appts. for clinic visits and test Exclusion Criteria: * Treatment within last 30 days with a drug that has not received regulatory approval for any indication. * Patients who weigh less than 40 kg or greater than 70 kg. * Patients with documented history of Bipolar I or II disorder, or psychosis * Patients with documented history of autism, asperger's syndrome or pervasive developmental disorder

Locations (21)

Outcomes

Primary Outcomes

Assess the difference in maintenance of response at 52 weeks between atomoxetine dosed at 0.8mg/kg/day vs.1.4 mg/kg/day measured by ADHDRS-IV-Parent:Inv

Secondary Outcomes

Assess the relationship between different dosing titrations & tolerability at 4 wks, & efficacy at 8 wks; effect of atomoxetine on adaptive,family functioning, academic performance, GPA, health status,health risk behaviors at 8 wks & 52 wks

Data from ClinicalTrials.gov

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Pasadena, California, United States

Rolling Hills Estates, California, United States

Spring Valley, California, United States

Norwich, Connecticut, United States

West Palm Beach, Florida, United States

Atlanta, Georgia, United States

Libertyville, Illinois, United States

Rochester Hills, Michigan, United States

St Louis, Missouri, United States

Las Vegas, Nevada, United States

...and 11 more locations