Status:
COMPLETED
Impact of Strattera and Behavior Therapy on the Home and School Functioning of Children With ADHD
Lead Sponsor:
State University of New York at Buffalo
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-12 years
Phase:
PHASE4
Brief Summary
Background: Multiple studies have found Atomoxetine (Strattera) to be efficacious but there is only one published study specifically designed to evaluate its efficacy in school settings. In this 7 wee...
Detailed Description
The objectives were evaluated in an 8 week open label trial of where half of the participants were randomly assigned to receive (ATX+BT) while the rest received only ATX. An open label design was empl...
Eligibility Criteria
Inclusion
- meet DSM-IV diagnostic criteria for ADHD-combined type;
- estimated IQ of 75 or higher;
- agree to comply with the randomly assigned treatment condition;
- enrolled in full time school at first grade level or higher; AND
- have a primary teacher available to complete ratings for the entire study duration.
Exclusion
- current or past history of seizures (not including benign febrile seizures) or other neurological disorders;
- physical conditions that preclude administration of Strattera or other medical illness that might confound study results or increase the safety risk to subjects exposed to study treatments (i.e. marked cardiac conduction delay, etc.);
- prior failed trial of Strattera defined as 3 weeks or more on a daily dose of Strattera of at least .8mg/kg or a documented inability to tolerate at least .8mg/kg/day;
- serious forms of psychopathology other than ADHD, such autism, bipolar disorder, schizophrenia or any other psychopathology requiring urgent treatment with psychotropic medication; OR
- children for whom discontinuation of their current psychotropic medication would represent a serious risk to themselves or others.
- The presence of Oppositional Defiant Disorder (ODD), Conduct Disorder (CD) or learning disabilities will not result in exclusion from the study as they are commonly occurring comorbidities that have not been found to moderate response to ADHD treatments (Jensen et al., 2001). Enrollment in special education services will also not be an exclusionary criteria as work by this research group has found that such services do not affect response to ADHD treatments (Niemic, Fabiano, Pelham, \& Fuller, 2002).
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00918567
Start Date
January 1 2007
End Date
September 1 2008
Last Update
October 20 2020
Active Locations (1)
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1
Cennter for Children and Families
Buffalo, New York, United States, 14214