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

Phase 3CompletedNCT00191698

Eli Lilly and Company226 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

226

Conditions

Attention Deficit Hyperactivity Disorder Oppositional Defiant Disorder

Interventions

atomoxetine hydrochlorideDRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (16)

Outcomes

Primary Outcomes

Mean reduction in ODD symptoms using the Swanson, Nolan and Pelham Rating Scale-Revised (SNAP-IV), atomoxetine vs placebo

Time frame: over 8 weeks

Secondary Outcomes

Mean change in the investigator-rated SNAP-IV ADHD subscales, atomoxetine vs placebo

Time frame: over 8 weeks

Mean change in ratings on the Oppositional subscale of the SNAP-IV

Time frame: 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.

Time frame: over 4 weeks

Mean change in ratings on the Clinical Global Impressions-Severity (CGI-S).

Time frame: over 8 weeks

Psychosocial functioning as measured by the total score on the Attention Deficit Hyperactivity Disorder Impact Module (AIM).

Time frame: over 8 weeks

Environmental stress exacerbation of ODD symptoms by Social Readjustment Rating Scale (SRRS).

Time frame: 8 weeks, 12 weeks

Adverse events (AEs)

Time frame: over 1 year

Data from ClinicalTrials.gov

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Wallsend, New South Wales, Australia

Parkville, Victoria, Australia

Antwerp, Belgium

Brussels, Belgium

Leuven, Belgium

Risskov, Denmark

Helsinki, Finland

Mannheim, Germany

Ulm, Germany

Nijmegen, Netherlands

...and 6 more locations