Attention-Deficit/Hyperactivity Disorder, Comorbid Dyslexia
Conditions
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.
Interventions
DRUGAtomoxetine
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To assess the effect of atomoxetine on educational testing, working memory,and adaptive functioning throughout 16 weeks. | — |
Countries
United States
Outcome results
None listed