Status:
COMPLETED
A Study Comparing the Effect of Atomoxetine Versus Other Standard Care Therapy on the Long Term Functioning in Attention-Deficit/Hyperactivity Disorder (ADHD) Children and Adolescents
Lead Sponsor:
Eli Lilly and Company
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-16 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate that atomoxetine is superior to other early standard therapy (any treatment that investigator considers is appropriate to initiate for the treatment of Atte...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 6 to 16 years old
- Diagnosis of ADHD according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM IV) confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version (SADS PL)
- Pharmacological naïve
- Normal intelligence as assessed by investigator
- Each patient (and/or legally authorized patient representative where required by local law) must understand the nature of the study and must sign an Informed Consent Document.
Exclusion
- Exclusion criteria
- History of bipolar disorder, any history of psychosis or autism spectrum disorder
- History of any seizure disorder
- Significant prior or current medical conditions
- History of alcohol or drug abuse within the past 3 months
- Patients who are taking concurrently any of the excluded medications in the study.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
399 Patients enrolled
Trial Details
Trial ID
NCT00447278
Start Date
March 1 2007
End Date
July 1 2009
Last Update
April 27 2010
Active Locations (35)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 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
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 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.
Hoboken, Belgium, 2660
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 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.
Leuven, Belgium, 3000
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 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.
Amiens, France, 80084