Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With ADHD

Study Overview
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Brief Summary
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The purpose of this protocol is to investigate the acute treatment efficacy, safety, and tolerability of atomoxetine on a once-daily dosing strategy in Taiwanese children and adolescents with ADHD.

Official Title
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Efficacy, Tolerability, and Safety of Once-Daily Atomoxetine Hydrochloride Versus Placebo in Taiwanese Children and Adolescents With Attention-Deficit/Hyperactivity Disorder

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: Atomoxetine Hydrochloride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must have ADHD that meet DSM-IV disease diagnostic criteria as well as severity criteria Subjects must be aged 6 to 16 years Subjects must not have taken any medication used to treat ADHD or they must have completed the washout procedures Subjects must be able to swallow capsules Subjects must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as being without evidence of significant general intellectual deficit and expected to achieve a score of 80 or more if formal IQ testing were administered. Exclusion Criteria: Weigh less than 20 kg or more than 60 kg at study entry Have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder Meet DSM-IV criteria for an anxiety disorder as assessed by the investigator Have a history of any seizure disorder (other than febrile seizures) or prior ECG abnormalities related to epilepsy, or subjects who have taken (or are currently taking) anticonvulsants for seizure control Subjects who have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atomoxetine Hydrochloride|nan|
|Drug: Placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test the hypothesis that atomoxetine administered as a single-daily dose provides superior efficacy compared with placebo in Taiwanese children and adolescents with ADHD |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the improvement in symptoms associated with ADHD in children and adolescents achieved by once-daily dosing of atomoxetine or placebo |  |  | 
| Compare the reduction in school-related symptoms between atomoxetine and placebo |  |  | 
| Assess the safety and tolerability of once-daily dosing of atomoxetine |  |  |