ADHD
Conditions
Brief summary
Evaluate the behavioral effects of ADDERALL XR versus STRATTERA under controlled conditions utilizing the SKAMP deportment scale.
Interventions
DRUGMixed amphetamine salts (ADDERALL XR)
DRUGAtomoxetine hydrochloride
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Primary diagnosis of ADHD combined subtype or predominantly hyperactive-impulsive subtype, based on psychiatric evaluation * Capable of understanding and following classroom instructions * Generally functioning academically at age-appropriate levels
Exclusion criteria
* ADHD, predominantly inattentive subtype * Controlled or uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms such as PTSD, psychosis, bipolar disease, severe OCD, severe depressive or severe anxiety disorder * Documented history of aggressive behavior serious enough to preclude participation in regular classroom activities * Documented allergies or intolerance to either of the active treatments or tricyclic antidepressants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in SKAMP deportment scores from baseline to endpoint (averaged across Days 7, 14, 21) | Approximately 3 weeks |
Secondary
| Measure | Time frame |
|---|---|
| PERMP, SKAMP attention scale, CGI, CGIS-P, Peds QL | Approximately 3 weeks |
| treatment-emergent adverse events | approximately 3 weeks |
Countries
United States
Outcome results
None listed