Phase 4
N=110
Effects of Atomoxetine on Brain Activation During Attention & Reading Tasks in Participants With ADHD & Comorbid Dyslexia
Attention Deficit Hyperactivity Disorder · Dyslexia
Bottom Line
View on ClinicalTrials.gov: NCT00716274 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) — -0.056; -0.033; -0.061; 0.010 Change-from-baseline (BOLD response)
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
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Endpoint in Functional Magnetic Resonance Imaging (fMRI) Activation in Participants With Dyslexia Alone (Pseudoword Rhyming and Semantic-category) |
-0.056; -0.033; -0.061; 0.010; -0.038; -0.006 | — |
| PRIMARY Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Attention Tasks) |
— | — |
| PRIMARY Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks) |
— | — |
| PRIMARY Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks) |
— | — |
| PRIMARY Change From Baseline to Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version (ADHDRS) Total Score in the ADHD or ADHD + Dyslexia |
-11.04; -7.53; -13.85; -1.63 | — |
| PRIMARY Change From Baseline to Endpoint in Woodcock Johnson Tests of Achievement (WJ III) Word Attack Total Score in Participants With Dyslexia Alone |
-3.57; 2.92 | — |
| SECONDARY Change From Baseline to Endpoint in Basic Reading Skills Cluster WJ III in Participants With Dyslexia Alone |
-2.81; 2.25 | — |
| SECONDARY Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia |
-0.90; 14.59; 1.01; 3.69 | — |
| SECONDARY Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With Dyslexia Alone |
0.88; 2.77; 0.48; 2.53; 1.04; -1.73 | — |
| SECONDARY Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD + Dyslexia |
-3.41; 2.61; 2.02; 0.80; 1.71; -0.90 | — |
| SECONDARY Change From Baseline to Endpoint in WJ III Individual Test Scores in Participants With ADHD Alone |
-2.70; -4.98; -2.92; -1.40; 2.60; 0.46 | — |
| SECONDARY Change From Baseline to Endpoint in Comprehensive Test of Phonological Processing (CTOPP) Composite Scores in Participants With Dyslexia Alone |
4.01; 2.69; 5.62; 0.62; 0.19; -1.00 | — |
| SECONDARY Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD + Dyslexia |
4.60; 1.35; 2.33; 3.43; -0.71; 0.21 | — |
| SECONDARY Change From Baseline to Endpoint in CTOPP Composite Score in Participants With ADHD Alone |
3.66; 7.00; 3.70; 3.48; 2.36; 1.63 | — |
| SECONDARY Change From Baseline to Endpoint in Gray Oral Reading Tests-4 (GORT-4) in Participants With Dyslexia Alone |
0.24; -0.44; -0.10; -0.72; -0.17; -0.65 | — |
| SECONDARY Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia |
0.22; 0.17; -0.28; -0.61; -2.23 | — |
| SECONDARY Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone |
0.36; -0.35; -1.29; 0.15; -0.54; -0.38 | — |
| SECONDARY Change From Baseline to Endpoint Test of Word Reading Efficiency (TOWRE) Total Score in Participants With Dyslexia Alone |
2.21; -0.17 | — |
| SECONDARY Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia |
3.74; 1.38; 2.03; 1.37 | — |
| SECONDARY Change From Baseline to Endpoint in Working Memory Test Battery for Children (WMTB-C) in Participants With Dyslexia Alone |
0.74; 0.94; 0.34; 0.97; 0.61; 0.50 | — |
| SECONDARY Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia |
-1.25; 1.83; -4.48; -4.40; 2.34; 2.28 | — |
| SECONDARY Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone |
2.56; -0.97; -1.22; -1.71; -1.23; 1.71 | — |
| SECONDARY Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone |
-6.96; 7.13 | — |
| SECONDARY Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone |
3.02; 0.27 | — |
| SECONDARY Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone |
2.79; -1.01; 2.92; -4.08; 11.03; -1.53 | — |
| SECONDARY Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia |
-2.65; -2.62; 0.50; -1.07; 0.64; -4.08 | — |
| SECONDARY Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone |
-1.56; -0.58; -3.89; -1.61; 5.15; -3.62 | — |
| SECONDARY Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone |
-1.19; 2.06; -6.96; -1.76; 7.24; -2.42 | — |
| SECONDARY Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia |
3.54; 5.29; -2.65; 0.12; 2.65; 1.21 | — |
| SECONDARY Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone |
-0.33; 9.67; 3.59; 0.84; 1.53; 3.51 | — |
| SECONDARY Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone |
0.27; -0.64; 0.40; -0.69; 0.52; -0.64 | — |
| SECONDARY Change From Baseline to Endpoint in GORT-4 in Participants With ADHD + Dyslexia |
0.22; 0.17; -0.28; -0.61; -2.23 | — |
| SECONDARY Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone |
0.36; -0.35; -1.29; 0.15; -0.54; -0.38 | — |
| SECONDARY Change From Baseline to Endpoint in Participants in TOWRE Total Score With Dyslexia Alone |
3.20 | — |
| SECONDARY Change From Baseline to Endpoint in Participants in TOWRE Total Score With ADHD or ADHD + Dyslexia |
2.77; 6.75 | — |
| SECONDARY Change From Baseline to Endpoint in Participants in WMTB-C With Dyslexia Alone |
0.47; 1.29; 0.75; -0.96; 1.25; 1.91 | — |
| SECONDARY Change From Baseline to Endpoint in Participants in WMTB-C With ADHD + Dyslexia |
0.06; -4.12; 3.05; 1.78; 0.56; -0.22 | — |
| SECONDARY Change From Baseline to Endpoint in Participants in WMTB-C With ADHD Alone |
3.75; -3.37; 1.25; 1.12; 3.65; -1.09 | — |
| SECONDARY Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone |
-6.96; 7.13 | — |
| SECONDARY Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia |
-0.90; 14.59; 1.01; 3.69 | — |
| SECONDARY Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With Dyslexia Alone |
12.60 | — |
| SECONDARY Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD +Dyslexia |
-12.96; -18.76 | — |
| SECONDARY Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Pseudoword Rhyming, Semantic-category) |
— | — |
| SECONDARY Change From Baseline to Endpoint in fMRI Activation in Participants With Dyslexia Alone (Stroop Tasks) |
— | — |
| SECONDARY Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Pseudoword Rhyming and Semantic-category Tasks) |
— | — |
| SECONDARY Change From Baseline to Endpoint in fMRI Activation in Participants With ADHD or ADHD + Dyslexia (Stroop Tasks) |
— | — |
| SECONDARY Change From Baseline to Endpoint in WJ III Individual Scores in Participants With Dyslexia Alone |
2.79; -1.01; 2.92; -4.08; 11.03; -1.53 | — |
| SECONDARY Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD + Dyslexia |
-2.65; -2.62; 0.50; -1.07; 0.64; -4.08 | — |
| SECONDARY Change From Baseline to Endpoint in WJ III Individual Scores in Participants With ADHD Alone |
-1.56; -0.58; -3.89; -1.61; 5.15; -3.62 | — |
| SECONDARY Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With Dyslexia Alone |
-1.19; 2.06; -6.96; -1.76; 7.24; -2.42 | — |
| SECONDARY Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD + Dyslexia |
3.54; 5.29; -2.65; 0.12; 2.65; 1.21 | — |
| SECONDARY Change From Baseline to Endpoint in CTOPP Composite Scores in Participants With ADHD Alone |
-0.33; 9.67; 3.59; 0.84; 1.53; 3.51 | — |
| SECONDARY Change From Baseline to Endpoint TOWRE Total Score in Participants With Dyslexia Alone |
-0.17; 4.17 | — |
| SECONDARY Change From Baseline to Endpoint in TOWRE Total Score in Participants With ADHD or ADHD + Dyslexia |
3.74; 1.38; 2.03; 1.37 | — |
| SECONDARY Change From Baseline to Endpoint in GORT-4 in Participants With Dyslexia Alone |
0.27; -0.64; 0.40; -0.69; 0.52; -0.64 | — |
| SECONDARY Change From Baseline to Endpoint in GORT-4 in Participants With ADHD+ Dyslexia |
0.37; 0.31; 0.07; 0.45; 0.33; 0.52 | — |
| SECONDARY Change From Baseline to Endpoint in GORT-4 in Participants With ADHD Alone |
0.36; -0.35; -1.29; 0.15; -0.54; -0.38 | — |
| SECONDARY Change From Baseline to Endpoint in WMTB-C in Participants With Dyslexia Alone |
-1.77; 0.45; 3.98; 1.84; -0.68; -1.90 | — |
| SECONDARY Change From Baseline to Endpoint WMTB-C in Participants With ADHD + Dyslexia |
-1.25; 1.83; -4.48; -4.40; 2.34; 2.28 | — |
| SECONDARY Change From Baseline to Endpoint WMTB-C in Participants With ADHD Alone |
2.56; -0.97; -1.22; -1.71; -1.23; 1.71 | — |
| SECONDARY Change From Baseline to Endpoint in BADD-A Total Score in Participants With Dyslexia Alone |
-6.96; 7.13 | — |
| SECONDARY Change From Baseline to Endpoint in BADD-A Total Score in Participants With ADHD or ADHD + Dyslexia |
-0.90; 14.59; 1.01; 3.69 | — |
| SECONDARY Change From Baseline to Endpoint in ADHDRS-IV Total Score in Participants With Dyslexia Alone |
3.02; 0.27 | — |
| SECONDARY Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Participants With ADHD or ADHD + Dyslexia |
-0.32; -6.38; -6.29; -8.83 | — |
| SECONDARY The Number of Participants With Treatment Emergent Adverse Events (TEAE) in Participants With Dyslexia |
13; 11 | — |
| SECONDARY The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia. |
2; 2; 10; 3; 4; 8 | — |
| SECONDARY The Number of Participants With TEAE in Participants With Dyslexia |
3; 2; 8 | — |
| SECONDARY The Number of Participants With TEAE in Participants With ADHD or ADHD+Dyslexia. |
2; 2; 10; 3; 4; 8 | — |
| SECONDARY Number of Participants With Adverse Events |
35; 31; 8; 8; 25 | — |
| SECONDARY Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants |
-0.37; -3.58; 0.79; 0.47; 7.84; 1.95 | — |
| SECONDARY Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants |
3.63; 2.05; 0.63 | — |
| SECONDARY Change From Baseline to Endpoint in GORT-4 in Healthy Participants |
0.74; 0.68; 0.74; -0.16; -3.42 | — |
| SECONDARY Change From Baseline to Endpoint TOWRE Total Score in Healthy Participants |
0.20 | — |
| SECONDARY Change From Baseline to Endpoint in WMTB-C in Healthy Participants |
2.47; -0.95; 1.79; 0.58; 1.63; 1.11 | — |
| SECONDARY Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants |
5.74 | — |
| SECONDARY Change From Baseline to Endpoint in ADHDRS-IV Total Score in Healthy Participants |
0.15 | — |
| SECONDARY Change From Baseline to Endpoint in WJ III Individual Scores in Healthy Participants |
-0.37; -3.58; 0.79; 0.47; 7.84; 1.95 | — |
| SECONDARY Change From Baseline to Endpoint in CTOPP Composite Scores in Healthy Participants |
3.63; 2.05; 0.63 | — |
| SECONDARY Change From Baseline to Endpoint in GORT-4 in Healthy Participants |
0.74; 0.68; 0.74; -0.16; -3.42 | — |
| SECONDARY Change From Baseline to Endpoint in TOWRE Total Score in Healthy Participants |
4.05 | — |
| SECONDARY Change From Baseline to Endpoint in WMTB-C in Healthy Participants |
2.47; -0.95; 1.79; 0.58; 1.63; 1.11 | — |
| SECONDARY Change From Baseline to Endpoint in BADD-A Total Score in Healthy Participants |
5.74 | — |
| SECONDARY Change From Baseline to Endpoint in ADHDRS-IV-Parent: Inv Total Score in Healthy Participants |
1.17 | — |
Summary
This study will evaluate the effects of atomoxetine on brain activation during attention and reading tasks via functional Magnetic Resonance Imaging (fMRI) in participants ages 10 to 16 years old with ADHD and comorbid dyslexia
Eligibility Criteria
Inclusion Criteria
- Participants in the ADHD-only or ADHD+dyslexia groups must meet DSM-IV-TR criteria for ADHD
- Participants in the dyslexia-alone group or ADHD+dyslexia groups must meet criteria for dyslexia
- Participants must achieve a score of 80 or more on the Full Scale Intelligence Quotient
- Child or adolescent participants 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 & all related tests
- Participants for healthy control group do not meet DSM-IV-TR criteria for ADHD and/or dyslexia
- Participants for healthy control group must achieve a score of at least 80 but not >120 on the Full Scale Intelligence Quotient
Exclusion Criteria
- Participants who weigh less than 25.1 kilogram (kg) or greater than 70 kg.
- Participants with severe allergies to more than 1 class of medications or who have had multiple adverse drug reactions
- Participants with prior diagnosis of bipolar I or bipolar II disorder or psychosis
- Participants with documented history of autism, Asperger's syndrome, or pervasive developmental disorder
- Females who are pregnant or breastfeeding
- Participants treated with atomoxetine at a therapeutic dose (1.2 mg/kg/day) for at least 4 to 6 weeks
Data sourced from ClinicalTrials.gov (NCT00716274). 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.