Status:
COMPLETED
Comparison of Atomoxetine and Placebo in Children and Adolescents With ADHD and ODD
Lead Sponsor:
Eli Lilly and Company
Conditions:
Attention Deficit Hyperactivity Disorder
Oppositional Defiant Disorder
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT00191698
Start Date
December 1 2003
End Date
November 1 2007
Last Update
October 31 2008
Active Locations (16)
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1
For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Wallsend, New South Wales, Australia, 2287
2
For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Parkville, Victoria, Australia, 3052
3
For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Antwerp, Belgium, 2020
4
For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Brussels, Belgium, 1200