Phase 4
N=121
Comparison of Atomoxetine and Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) and/or Reading Disorder (RD)
Attention Deficit Hyperactivity Disorder · Reading Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00191906 ↗Enrolled (actual)
121
Serious AEs
0.0%
Results posted
Apr 2010
Primary outcome: Primary: Stop Signal Reaction Time (SSRT) as Derived From the Stop Signal Reaction Time Paradigm — 299.90; 308.82; 265.61; 260.51 milliseconds (msec) — p=0.504
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Atomoxetine Hydrochloride (Drug); placebo (Drug)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stop Signal Reaction Time (SSRT) as Derived From the Stop Signal Reaction Time Paradigm |
299.90; 308.82; 265.61; 260.51; 277.38; 292.53 | 0.504 |
| SECONDARY Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset |
7.95; 11.22 | 0.970 |
| SECONDARY Change From Baseline in Mean Stop Signal Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset |
-0.25; -34.0; 0.05 | 0.579 |
| SECONDARY Lexical Decision Task Mean Reaction Time: Correct Words |
1182.9; 1291.9; 1172.4; 1198.6; 1201.9; 1305.9 | 0.005 sig |
| SECONDARY Lexical Decision Task Mean Reaction Time: Pseudo Words |
1403.0; 1475.4; 1365.0; 1412.2; 1426.1; 1487.0 | 0.097 |
| SECONDARY Working Memory by Corsi Block Tapping Test (CBTT) |
5.29; 4.98; 5.50; 5.14; 5.92; 5.29 | 0.003 sig |
| SECONDARY Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total Score |
30.86; 35.20; 22.44; 35.17; 26.65; 35.18 | <0.001 sig |
| SECONDARY Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Inattention Subscale |
15.27; 17.82; 12.25; 18.28; 13.76; 18.05 | <0.001 sig |
| SECONDARY Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Hyperactivity-Impulsivity Subscale |
15.51; 17.24; 10.32; 17.03; 12.91; 17.13 | <0.001 sig |
| SECONDARY Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and Scored - Total T-Score |
-1.91; -1.48; -2.76; -1.48; -2.34; -1.48 | <0.001 sig |
| SECONDARY Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Improvement Scale |
3.69; 3.70; 2.98; 3.76; 3.34; 3.73 | 0.094 |
| SECONDARY Clinical Global Impression-Attention Deficit Hyperactivity Disorder-Severity Scale |
4.05; 3.73; 3.65; 4.34; 3.85; 4.04 | 0.312 |
| SECONDARY Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudohomophones |
-230.40; -339.17 | 0.508 |
| SECONDARY Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C to Normal Control Group in >=10 Year Old Subset: Pseudo Words |
-523.20; -536.00 | 0.769 |
| SECONDARY Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudohomophones |
-170.81; -241.00; -254.86 | 0.302 |
| SECONDARY Change From Baseline in Phonological Task Mean Reaction Time Comparison of ADHD-C+RD and RD to Reading Disordered Control Group in >=10 Year Old Subset: Pseudo Words |
-113.06; -213.00; -368.14 | 0.070 |
Summary
To test the hypothesis that a 4 week treatment with atomoxetine is more effective than placebo in patients with combined type Attention Deficit/Hyperactivity Disorder (ADHD), patients with only Reading Disorder, and patients with combined type ADHD and Reading Disorder.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis with Attention Deficit Hyperactivity Disorder and/or Reading Disorder
Exclusion Criteria
- Patients with Conduct Disorder
- Patients who have a history of Bipolar I or II Disorder, psychosis, or Pervasive Development Disorder.
- Patients who have a current diagnosis of Vocal Tic Disorder, Obsessive Compulsive Disorder, Major Depressive Disorder, Post Traumatic Stress Disorder, Anxiety Disorder, and certain other learning disorders.
Data sourced from ClinicalTrials.gov (NCT00191906). 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.