Phase 4
Completed N=125
Comparison of Atomoxetine Versus Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Source: ClinicalTrials.gov NCT00546910 ↗Enrolled (actual)
125
Serious AEs
0.0%
Results posted
Jun 2010
Primary outcomePrimary: Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 — 0.62; 0.84; 0.65; 0.76 Q-scores — p=<0.001
Summary
This is a two-arm, parallel, randomized, double-blind, placebo-controlled Phase 4 multicenter trial to compare the whole day efficacy of atomoxetine versus placebo in children aged 6 through 12 years with Attention-Deficit/Hyperactivity Disorder (ADHD) treated in an inpatient, day-patient and outpatient setting in Germany. Core symptoms will be measured during once or bi-weekly visits, three times per visit-day, by a computer based Continuous Performance Test. Following an initial 3-28-day screening and washout phase, patients will be assigned to double-blind treatment with atomoxetine or placebo. In the verum arm, a one-week atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7 week period at the target dose of 1.2 mg/kg per day.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Computer-based Continuous Performance Test (cb- CPT; Qbtech AB, Sweden), Variable: Hyperactivity (Includes Time Active [TA], Distance [DIS], Area [AR], Microevents [ME], Motion Simplicity [MS]) Q-scores At Week 8 |
0.62; 0.84; 0.65; 0.76; 0.66; 0.85 | <0.001 sig |
| PRIMARY Change From Baseline cb CPT Variable: Inattention (Includes Reaction Time Variation[RTV], Omission Error [OR], Mean Reaction Time [mRT], Normalized Variation Of Reaction Time [nVRT]) Q-scores At Week 8 |
2.93; 2.49; 2.95; 2.48; 2.63; 2.19 | <0.001 sig |
| PRIMARY Change From Baseline cb CPT Variable: Impulsivity (Includes Commission Error [CE], Anticipatory Response [AR]) Q-scores At Week 8 |
-0.68; -0.89; -0.65; -0.85; -0.80; -0.87 | <0.001 sig |
| PRIMARY Change From Baseline cb CPT Variable: Other (Includes Error Rate [ER] and Multi Response [MR]) Q-scores At Week 8 |
0.37; 0.30; 0.52; 0.41; 0.37; 0.41 | <0.001 sig |
| SECONDARY Change From Baseline Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered And Scored (ADHDRS-IV-Parent:Inv) Total Score At Week 8 |
-17.19; -4.76; -15.78; -4.21 | <0.001 sig |
| SECONDARY Change From Baseline Clinical Global Impressions-Severity of ADHD (CGI-S-ADHD) Score at Week 8 |
-1.78; -0.63; -1.52; -0.40 | <0.001 sig |
| SECONDARY Change From Baseline Weekly Rating Of Evening and Morning Behavior-Revised-Investigator Rated, Total and Subscores at Week 8 |
-10.72; -5.10; -9.59; -3.90; -6.91; -3.57 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Male or female patients who are at least 6 years of age, and who will not have reached their 13th birthday
- Diagnosis of ADHD
- Normal intelligence
- Able to swallow capsules
Exclusion Criteria
- Weight less than 20 kg or more than 60 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 prolongation, inherited cardiac disorders
Data sourced from ClinicalTrials.gov (NCT00546910). 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. Informational only — not medical advice.