Treatment of ADHD With Atomoxetine in Children & Adolescents With ADHD & Comorbid Dyslexia (NCT00607919) | Clinical Trial Compass
CompletedPhase 4
Treatment of ADHD With Atomoxetine in Children & Adolescents With ADHD & Comorbid Dyslexia
United States209 participantsStarted 2008-03
Plain-language summary
This study will evaluate the effect of atomoxetine in treating Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in children and adolescents with ADHD and comorbid reading disability (dyslexia)
Who can participate
Age range10 Years – 16 Years
SexALL
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Inclusion Criteria:
* patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for Attention-Deficit/Hyperactivity Disorder (ADHD)
* patients must achieve a score of 80 or more on the Full Scale Intelligence Quotient
* child or adolescent patients must be 10 to 16 years old
* must be able to communicate in English
* must be able to swallow capsules
* be reliable to keep appointments for clinic visits and all related tests
Exclusion Criteria:
* patients who weigh less than 25 Kg or greater than 70 Kg
* patients with a history of alcohol or drug abuse on a repeated basis within the past 3 months
* patients with documented history of autism, Asperger's syndrome or pervasive developmental disorder
* females who are pregnant or breastfeeding
* patients with a history of severe allergy to more than one class of medications
* patients with documented history of bipolar I or bipolar II disorder, or psychosis
What they're measuring
1
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint