Evaluation of Continuous Symptom Treatment of ADHD

Study Overview
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Brief Summary
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The purpose of this study is to test the hypothesis that atomoxetine administered orally, once a day, at doses up to 1.4 mg/kg/day for approximately 6 weeks given in the morning is superior to placebo in children with ADHD.

Official Title
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Evaluation of Continuous Symptom Treatment of ADHD: A Placebo-Controlled Double-Blind Assessment of Morning-Dosed or Evening-Dosed Strattera

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: Patients must have ADHD that meets disease diagnostic criteria as defined by DSM-IV-Revised Males or females who are at least 6 years old and no more than 12 years old prior to visit 2 Patients must be able to swallow capsules Patients 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 70 or more if formal IQ testing were administered. Laboratory results must show no significant abnormalities (significance is defined as laboratory values requiring acute medical intervention, indicating a serious medical illness, or requiring further medical evaluation in the judgment of the investigator) Exclusion Criteria: Patients who weigh less than 20 kg or greater than 65 kg at study entry (visit 1) Patients who have a documented history of bipolar I or bipolar II disorder, or psychosis Patients who have documented autism, Asperger's syndrome, or pervasive developmental disorder. Other comorbid psychiatric disorders are not excluded provided that the diagnosis of ADHD predates the comorbid disorder, and that the ADHD symptoms are the primary source of impairment for the patient Patients taking any antipsychotic medication during the 4 weeks prior to visit 1 are not eligible.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 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?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test the hypothesis that atomoxetine administered orally, once a day, at doses up to 1.4 mg/kg/day for approximately 6 weeks given in the morning is superior to placebo in children with ADHD |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test the hypothesis that atomoxetine administered once daily in the evening provides superior efficacy compared with placebo in children with ADHD |  |  | 
| Test the hypothesis that atomoxetine administered once daily in the morning provides superior efficacy in the evenings compared with placebo in children with ADHD |  |  | 
| Test the hypothesis that atomoxetine administered once daily in the morning provides superior efficacy in the mornings (before daily dosing, i.e., nearly 24 hrs since last dosing) compared with placebo in children with ADHD based on the CGIP-M |  |  | 
| To assess the effect of dosing atomoxetine in the morning versus placebo on measures of executive functioning |  |  | 
| Test the hypothesis that atomoxetine administered once daily in the morning provides superior efficacy compared with placebo for measures of adaptive functioning in children with ADHD |  |  | 
| Test the hypothesis that atomoxetine administered once daily in the evening provides superior efficacy in the evenings (before daily dosing, i.e., nearly 24 hrs since last dosing) compared with placebo in children with ADHD |  |  | 
| Test the hypothesis that atomoxetine administered once daily in the morning provides superior efficacy in the mornings (before daily dosing, i.e., nearly 24 hrs since last dosing) compared with placebo in children with ADHD |  |  | 
| To examine the onset of action during the first week of treatment in the morning versus in the evening versus placebo |  |  | 
| To assess the effect of dosing atomoxetine in the evening versus placebo on measures of executive functioning |  |  | 
| To compare morning versus evening dosing versus placebo as assessed by the CGI-ADHD-S |  |  | 
| To assess the safety and tolerability of atomoxetine dosed in the morning versus in the evening versus placebo |  |  |