Treatment With Atomoxetine Hydrochloride in Children and Adolescents With ADHD

Phase 4

Completed

• Conditions: Attention-Deficit/Hyperactivity Disorder; Comorbid Dyslexia

• Registration Number: NCT00191048
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purpose of this study is to assess the efficacy and safety of atomoxetine administered once daily in the treatment of children and adolescents with ADHD and comorbid dyslexia.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2006-03
• Status Verified: 2007-01
• Last Update Submitted: 2007-01-24
• Last Update Posted: 2007-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Patients with ADHD only or ADHD and Dyslexia
• At least 10 years old and no more than 16 years old
• IQ score of 80 or more
• Must be able to swallow capsules

Exclusion Criteria

• Have received treatment within last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
• Weigh less than 25 kg or greater than 70 kg
• Pregnant or breast feeding
• Documented history of bipolar I or II disorder, or psychosis
• Documented history of autism, Asperger's syndrome or pervasive developmental disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To assess the effect of atomoxetine,given for approximately 16 weeks, in the treatment of ADHD with Dyslexia as measured by the ADHDRS-IV-Parent:Inv

Secondary Outcome Measures

Name	Time	Method
To assess the effect of atomoxetine on educational testing, working memory,and adaptive functioning throughout 16 weeks.

Trial Locations

Locations (1)

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; 🇺🇸 Burlington, Vermont, United States