Treatment With Atomoxetine Hydrochloride in Children and Adolescents With ADHD
Phase 4
Completed
- Conditions
- Attention-Deficit/Hyperactivity DisorderComorbid 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
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