Comparison of Atomoxetine and Placebo in Children and Adolescents With ADHD and ODD

Study Overview
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Brief Summary
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The purpose of this trial is to test the effectiveness of atomoxetine in treating symptoms of ODD in children with ADHD and ODD.

Official Title
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A Randomized, Double-Blind Comparison of Atomoxetine Hydrochloride and Placebo in Child and Adolescent Outpatients With Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder

Conditions
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Attention Deficit Hyperactivity Disorder, Oppositional Defiant 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 are male or female outpatients who are at least 6 years of age and not more than 12 years of age at study entry. Patients must meet DSM-IV diagnostic criteria for ADHD and ODD. If other comorbid conditions are present, either the ADHD or the ODD diagnosis must be the patient's primary diagnosis. Patients must have laboratory results, including serum chemistries, hematology, and urinalysis showing no significant abnormalities. Patients must have an ECG performed at study entry that is absent of any abnormality that, in the opinion of the physician, should exclude the patient. Exclusion Criteria: Patients who weigh less than 20 kg or greater than 60 kg at study entry. Patients who have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder. Patients who have a current diagnosis of Major Depressive Disorder ([MDD]; with or without psychotic features), PTSD, or CDRS-R total raw score >40 at study entry. Patients with a history of any seizure disorder. Patients determined by the investigator to be at serious suicidal risk.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Atomoxetine is administered at 1.2 mg/kg/day, PO for 8 weeks, followed by 1.2 or 2.4 mg/kg/day, PO for 4 weeks, open label administration can continue for up to one year | Drug: atomoxetine hydrochloride<br> <br> * Other names: Strattera;|
| Placebo Comparator: B<br>Placebo is administered by mouth, daily for 8 weeks. After 8 weeks, those randomized to placebo may be titrated to 1.2 mg/kg/day atomoxetine for the remainder of the study up to one year | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean reduction in ODD symptoms using the Swanson, Nolan and Pelham Rating Scale-Revised (SNAP-IV), atomoxetine vs placebo |  | over 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in the investigator-rated SNAP-IV ADHD subscales, atomoxetine vs placebo |  | over 8 weeks | 
| Mean change in ratings on the Oppositional subscale of the SNAP-IV |  | over 8 weeks | 
| Mean change in ADHD symptoms by ADHD subscales of the SNAP-IV, 2.4 mg/kg/day vs 1.2 mg/kg/day. |  | over 4 weeks | 
| Mean change in ratings on the Clinical Global Impressions-Severity (CGI-S). |  | over 8 weeks | 
| Psychosocial functioning as measured by the total score on the Attention Deficit Hyperactivity Disorder Impact Module (AIM). |  | over 8 weeks | 
| Environmental stress exacerbation of ODD symptoms by Social Readjustment Rating Scale (SRRS). |  | 8 weeks, 12 weeks | 
| Adverse events (AEs) |  | over 1 year |