A Double-Blind Placebo Controlled Study of Atomoxetine Hydrochloride for the Treatment of ADHD in Children and Adolescents With ADHD and Comorbid Dyslexia
Overview
- Phase
- Phase 4
- Intervention
- Atomoxetine
- Conditions
- Attention Deficit Hyperactivity Disorder
- Sponsor
- Eli Lilly and Company
- Enrollment
- 209
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief 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)
Investigators
Eligibility Criteria
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
Arms & Interventions
Atomoxetine
Atomoxetine will be administered at 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) given orally once daily in the morning. All eligible patients who complete the double-blind study period will have the option of participating in a 16-week open-label extension period in which patients will be treated with atomoxetine
Intervention: Atomoxetine
Placebo
Placebo will be packaged in the same way as experimental drug to enforce double-blind study design. Placebo will be administered orally once daily in the morning. All eligible patients who complete the double-blind study period will have the option of participating in a 16-week open-label extension period in which patients will be treated with atomoxetine.
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint
Time Frame: Baseline, 16 weeks
Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0-54. Least Square mean of change from baseline in ADHDRS is from a restricted maximum likelihood-based, mixed model repeated measures analysis which includes the effects of treatment, investigative site, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Secondary Outcomes
- Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint(Baseline, 16 weeks)
- Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 16 Endpoint(Baseline, 16 weeks)
- Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint(Baseline, 16 weeks)
- Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint(Baseline, 16 weeks)
- Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint(Baseline, 16 weeks)
- Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 16 Endpoint(Baseline, 16 weeks)
- Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint(Baseline, 16 weeks)
- Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 16 Endpoint(Baseline, 16 weeks)
- Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 16 Endpoint(Baseline, 16 weeks)
- Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint(Baseline, 16 weeks)
- Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 32 Endpoint(Baseline, 32 weeks)
- Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 32 Endpoint(Baseline, 32 weeks)
- Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint(Baseline, 32 weeks)
- Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint(Baseline, 32 weeks)
- Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 32 Endpoint(Baseline, 32 weeks)
- Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 32 Endpoint(Baseline, 32 weeks)
- Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint(Baseline, 32 weeks)
- Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 32 Endpoint(Baseline, 32 weeks)
- Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 32 Endpoint(Baseline, 32 weeks)
- Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint(Baseline, 32 weeks)