Attention Deficit Hyperactivity Disorder, Oppositional Defiant Disorder
Conditions
Brief summary
The purpose of this trial is to test the effectiveness of atomoxetine in treating symptoms of ODD in children with ADHD and ODD.
Interventions
DRUGatomoxetine hydrochloride
DRUGplacebo
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Mean change in the investigator-rated SNAP-IV ADHD subscales, atomoxetine vs placebo | 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 |
| Psychosocial functioning as measured by the total score on the Attention Deficit Hyperactivity Disorder Impact Module (AIM). | over 8 weeks |
Countries
Australia, Belgium, Denmark, Finland, Germany, Netherlands, Spain, United Kingdom
Outcome results
None listed