Phase 4
N=209
Treatment of ADHD With Atomoxetine in Children & Adolescents With ADHD & Comorbid Dyslexia
Attention Deficit Hyperactivity Disorder · Dyslexia
Bottom Line
View on ClinicalTrials.gov: NCT00607919 ↗Enrolled (actual)
209
Serious AEs
0.5%
Results posted
Dec 2011
Primary outcome: Primary: Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint — -20.01; -12.27 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Atomoxetine (Drug); Placebo (Drug)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint |
-20.01; -12.27 | <0.001 sig |
| SECONDARY Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint |
-8.23; -5.18; -6.26; -10.64; -7.79; -10.33 | — |
| SECONDARY Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 16 Endpoint |
-2.71; -1.99; -0.82; -4.48; -0.99; -2.27 | — |
| SECONDARY Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint |
1.75; 0.87; -0.41; 1.18; -0.07; -0.32 | — |
| SECONDARY Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint |
0.96; 0.95; 1.86; 0.88; -0.24; 0.27 | — |
| SECONDARY Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint |
0.71; 0.40; 0.95; 0.37; 0.65; -0.33 | — |
| SECONDARY Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 16 Endpoint |
1.92; 1.21; 1.77; 1.38; 1.19; 0.69 | — |
| SECONDARY Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint |
3.57; 1.63; 2.24; 7.34; -0.89; 2.17 | — |
| SECONDARY Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 16 Endpoint |
0.57; 0.53; 1.38; 6.06; 4.29; 7.49 | — |
| SECONDARY Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 16 Endpoint |
-7.82; -4.64; -8.24; -8.82; -1.64; -3.47 | — |
| SECONDARY Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint |
5.91; 4.23; 5.52; 3.62; 2.35; 3.56 | — |
| SECONDARY Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 32 Endpoint |
-9.8; -8.29; -13.84; -14.33; -23.64; -22.62 | — |
| SECONDARY Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 32 Endpoint |
-1.87; -2.89; -4.28; -4.19; -6.15; -7.08 | — |
| SECONDARY Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint |
2.73; -0.24; 1.69; 0.24; 2.31; 1.24 | — |
| SECONDARY Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint |
1.31; 1.90; 1.07; 0.71; 0.87; -0.05 | — |
| SECONDARY Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 32 Endpoint |
0.82; 0.95; 0.04; -0.30; 0.76; 1.10 | — |
| SECONDARY Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 32 Endpoint |
2.64; 5.33; 1.93; 4.62; 2.56; 1.52 | — |
| SECONDARY Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint |
3.67; 1.70; 6.53; 1.64; 3.85; 2.65 | — |
| SECONDARY Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 32 Endpoint |
1.57; 2.14; 9.10; 10.44; 10.67; 12.64 | — |
| SECONDARY Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 32 Endpoint |
-10.40; -10.83; -7.00; -7.89; -4.36; -5.43 | — |
| SECONDARY Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint |
6.02; 5.43; 4.29; 3.14; 6.76; 5.19 | — |
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)
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
Data sourced from ClinicalTrials.gov (NCT00607919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.