Open-Label Trial of Atomoxetine to Evaluate Academic Outcome in Children Ages 8-11 Years With Attention Deficit/Hyperactivity Disorder

Phase 3CompletedNCT00191880

Eli Lilly and Company100 enrolled

Overview

Open-label trial of Atomoxetine to Evaluate Academic Outcome in Children Ages 8-11 years with Attention- Deficit/Hyperactivity Disorder

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

atomoxetineDRUG

Eligibility

Sex: ALLMin age: 8 YearsMax age: 11 Years

Medical Language ↔ Plain English

Inclusion Criteria: -Patients must have ADHD, be psychotropic medication naive and be outpatients who are at least 8 years of age and not more than 10 years of age at Visit 1 (that is, not yet reached their 11 birthday) so that all year testing will be completed before the child reaches age 12. Exclusion Criteria: -Patients with current or past history of Bipolar I or II disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, conduct disorder, seizure disorder or serious suicidal risk are excluded

Locations (8)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Calgary, Canada

Outcomes

Primary Outcomes

The primary objective of this study is to assess the correlation of change from baseline to one year in ADHD symptoms as measured by the Attention Deficit/Hyperactivity Disorder Rating Scale- IV-

Parent Version: Investigator Administered and Scored,

total score, with change from baseline in academic achievement of medication-naive patients treated with atomoxetine at one year as measured by the total

of the composite scores of the broad reading, broad math, and broad language subtests of the Woodcock-Johnson Tests of Achievement (WJII)

Secondary Outcomes

To Assess the correlation of change from baseline to one year or at study discontinuation in ADHD symptoms as measured by the ADHDRS-IV-Parent:Inv with change from baseline with each of the academic achievement composite scores of the broad reading, broa

Data from ClinicalTrials.gov

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Edmonton, Canada

London, Canada

Montreal, Canada

Saskatoon, Canada

Scarborough, Canada

St. Johns, Canada

Toronto, Canada