A Study for Patients With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Academic Performance in Asian Children Aged 8 to 11 Years With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine Hydrochloride

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: Atomoxetine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atomoxetine<br>0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks. | Drug: Atomoxetine<br>* atomoxetine 0.5 mg/kg/day once a day (QD), by mouth (PO) starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.<br>* Other names: Strattera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Correlation was calculated between change from baseline and endpoint in ADHD-RS Total Score and change in SGA total score. ADHD-RS measures 18 symptoms associated with diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. SGA: Grades (0 to 100) in classes of Language, Math, and Science were obtained and average taken to get SGA Total Score between 0 and 100; higher scores indicating better grades/apptitude. Any ordinal grades were imputed to numerical grades based on communication with relevant schools. | Baseline, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Correlation was calculated between change from baseline and endpoint in ADHD-RS Total Score and change in separate SGA language, math, and science scores. ADHD-RS measures 18 symptoms associated with diagnosis of ADHD. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. SGA: separate language, math, and science school grades on a scale of 0-100, with higher scores indicating better grades/apptitude in the respective class. Any ordinal grades were imputed to numerical grades based on communication with relevant schools. | Baseline, 24 weeks | 
| Change From Baseline to 24 Week Endpoint in Academic Performance by School Grade Average (SGA) Total, and Separate Language, Math, and Science Scores | Separate school grades in the classes of Language, Math, and Science were obtained. A score between 0 and 100 was provided for each of the three classes, and the average taken to get a SGA Total Score between 0 and 100, with higher scores indicating better grades/apptitude in each class and overall. Any ordinal grades were imputed to numerical grades based on communication with relevant schools. | Baseline, 24 weeks | 
| Change From Baseline to 24 Week Endpoint in Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version:Investigator-Administered and Scored - Total Score | Measures the 18 symptoms contained in the DSM-IV diagnosis of Attention-Deficit/Hyperactivity Disorder. Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0 to 54. | Baseline, 24 weeks | 
| Change From Baseline to 24 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder - Severity Scale (CGI-ADHD-S) | Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients). | Baseline, 24 weeks | 
| CGI-ADHD-Improvement Scale (CGI-ADHD-I) at 24 Week Endpoint | Measures total improvement (or worsening) of a patient's ADHD symptoms from the beginning of treatment (1=very much improved, 7=very much worsened). | 24 weeks | 
| Change From Baseline to 24 Week Endpoint in Revised Conners' Parent Rating Scale: Short Form (CPRS-R:S) Attention-Deficit/Hyperactivity Disorder Index Score | A 27-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the parent to assess problem behaviors related to ADHD. Subscale assessed: ADHD Index. ADHD Index is the sum of items 1, 5, 7, 10, 13, 15, 17, 19, 21, 23, 25, and 27. Subscale total scores range from 0 to 36. Higher scores reflect more severe problem behaviors related to ADHD. | Baseline, 24 weeks |