Phase 4
Completed N=228
A Study for Patients With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine
Source: ClinicalTrials.gov NCT00471354 ↗Enrolled (actual)
228
Serious AEs
0.4%
Results posted
Dec 2009
Primary outcomePrimary: Correlation Between Change From Baseline and 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and School Grade Average (SGA) — -0.083 Spearman Correlation Coefficient — p=0.293
Summary
The purpose of the study is to investigate the relationship of changes in measures of academic performance and problem behaviors, to changes in core Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in Asian children treated with atomoxetine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation Between Change From Baseline and 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent:Investigator-Administered and Scored (ADHDRS-IV-Parent:Inv) Total Score and School Grade Average (SGA) |
-0.083 | 0.293 |
| SECONDARY Correlation Between Change From Baseline to 24 Week Endpoint in ADHDRS-IV-Parent:Inv Total Score and School Grade Averages in Separate Language, Math and Science Classes |
-0.086; -0.126; -0.058 | 0.276 |
| SECONDARY Change From Baseline to 24 Week Endpoint in Academic Performance by School Grade Average (SGA) Total, and Separate Language, Math, and Science Scores |
3.9; 4.1; 6.1; 4.7 | <0.001 sig |
| SECONDARY Change From Baseline to 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored - Total Score |
-18.8 | <0.001 sig |
| SECONDARY Change From Baseline to 24 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder - Severity Scale (CGI-ADHD-S) |
-2.1 | <0.001 sig |
| SECONDARY CGI-ADHD-Improvement Scale (CGI-ADHD-I) at 24 Week Endpoint |
2.3 | — |
| SECONDARY Change From Baseline to 24 Week Endpoint in Revised Conners' Parent Rating Scale: Short Form (CPRS-R:S) Attention-Deficit/Hyperactivity Disorder Index Score |
-9.8 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Male or female outpatients between 8 and 11 years of age at study entry
- Attention-Deficit/Hyperactivity Disorder (ADHD) meeting the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) disease diagnostic criteria
- Patients who have never received medications psychotropic medications specifically to treat ADHD, or if they have received medication, that the trial of the psychotropic medication(s) was of less than 1 month duration, and occurred more than 6 months prior to study entry
- Normal intelligence in the judgment of the investigator
- Must be able to swallow capsules
Exclusion Criteria
- Current or past history of bipolar I or II disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or conduct disorder
- History of seizure disorder or currently taking anticonvulsants for seizure control
- Serious suicidal risk as determined by investigator
- Cardiovascular disease; current or past history of hypertension
- Previous treatment with atomoxetine
Data sourced from ClinicalTrials.gov (NCT00471354). 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.