Phase 4
N=181
Comparison of Atomoxetine Versus Placebo in Children and Adolescents With ADHD and Comorbid ODD in Germany
Attention Deficit Hyperactivity Disorder · Oppositional Defiant Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00406354 ↗Enrolled (actual)
181
Serious AEs
1.7%
Results posted
Feb 2010
Primary outcome: Primary: Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) Oppositional Defiant Disorder: (ODD) Score — 8.6; 9.0; 12.0 units on a scale — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Atomoxetine (Drug); Placebo (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) Oppositional Defiant Disorder: (ODD) Score |
8.6; 9.0; 12.0 | <.001 sig |
| SECONDARY Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Combined Score |
22.9; 21.3; 29.6 | <.001 sig |
| SECONDARY Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Inattention Score |
11.1; 10.0; 14.1 | <.001 sig |
| SECONDARY Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): Hyperactivity/Impulsivity Score |
11.5; 11.1; 15.2 | <.001 sig |
| SECONDARY Parent-Rated Attention-Deficit Scale (FBB-HKS), Total Score: Severity |
1.2; 1.1; 1.5 | <.001 sig |
| SECONDARY Parent-Rated Oppositional Defiant/Conduct Disorders Scale (FBB-SSV): Total Score, Severity |
0.8; 0.8; 1.0 | 0.006 sig |
| SECONDARY Investigator-Rated Individual Target Behaviors (ITB-Inv): Intensity Score |
10.8; 11.9; 14.9 | 0.010 sig |
| SECONDARY Investigator-Rated Individual Target Behaviors (ITB-Inv): Frequency Score |
6.0; 6.6; 8.1 | 0.010 sig |
| SECONDARY Impact on Family Scale (FaBel), Total Impact Score |
54.2; 50.6; 53.8 | 0.406 |
| SECONDARY Clinical Global Impressions - Severity (CGI-S): ADHD Score |
3.5; 3.6; 4.3 | <.001 sig |
| SECONDARY Clinical Global Impressions - Severity (CGI-S): ODD Score |
3.6; 3.5; 4.3 | <.001 sig |
| SECONDARY Clinical Global Impressions - Severity (CGI-S): Combined ADHD and ODD Scores |
3.7; 3.5; 4.4 | <.001 sig |
| SECONDARY German Revised Children's Quality of Life Questionnaire (KINDL-R): Total Quality of Life Score |
66.0; 65.6; 60.7 | 0.021 sig |
| SECONDARY German Revised Children's Quality of Life Questionnaire (KINDL-R): Physical Well-Being Score |
69.1; 71.9; 78.1 | 0.017 sig |
| SECONDARY German Revised Children's Quality of Life Questionnaire (KINDL-R): Emotional Well-Being Score |
71.8; 73.0; 66.9 | 0.050 |
| SECONDARY German Revised Children's Quality of Life Questionnaire (KINDL-R): Self Esteem Score |
60.1; 57.3; 48.0 | <.001 sig |
| SECONDARY German Revised Children's Quality of Life Questionnaire (KINDL-R): Family Score |
63.7; 61.9; 54.7 | 0.015 sig |
| SECONDARY German Revised Children's Quality of Life Questionnaire (KINDL-R): Friends Score |
67.1; 61.3; 56.2 | 0.018 sig |
| SECONDARY German Revised Children's Quality of Life Questionnaire (KINDL-R): School Score |
63.4; 67.4; 60.5 | 0.138 |
| SECONDARY Number of Participants Discontinuing Treatment |
4; 8; 15; 2; 5; 4 | 0.016 sig |
| SECONDARY Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Initial Three Weeks of Study Treatment |
21; 18; 5; 19; 14; 6 | 0.102 |
| SECONDARY Number of Patients Who Experienced Clinically Relevant Categories of Adverse Events During Nine-Week Study Treatment Period |
25; 21; 6; 20; 14; 6 | 0.101 |
Summary
A three-arm, randomized, double-blind, placebo-controlled, Phase 4, multicenter study to compare the efficacy and safety of atomoxetine versus placebo in children and adolescents aged 6 through 17 years with attention-deficit/hyperactivity disorder (ADHD) and comorbid oppositional defiant disorder (ODD) who are treated as outpatients in Germany. After an initial 3- to 28-day screening and washout phase, participants will be assigned to double-blind treatment with atomoxetine or placebo. A 2 week up-titration period will be succeeded by a 7 week treatment period at the target dose. The primary efficacy measure will be the Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) ODD subscale score.
Eligibility Criteria
Inclusion Criteria
- Male or female outpatients who are at least 6 years of age, and who will not have reached their 18th birthday
- Diagnosis of ADHD and presence of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria A through C for ODD (NOTE: diagnosis for conduct disorder not exclusionary)
- Normal intelligence
- Able to swallow capsules
Exclusion Criteria
- Weigh less than 20 kilogram (kg) or more than 90 kg at study entry
- Prior treatment with atomoxetine
- History of seizure disorder, suicidal risk, alcohol or drug abuse within the past 3 months
- History of severe allergies or multiple adverse drug reactions
- Cardiovascular disorders: hypertension, unexplained cardiac signs or symptoms, QT (measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle) prolongation , inherited cardiac disorders
Data sourced from ClinicalTrials.gov (NCT00406354). 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.