Analog Classroom Study Comparison of ADDERALL XR With STRATTERA in Children Aged 6-12 With ADHD
Phase 4
Completed
- Conditions
- ADHD
- Interventions
- Drug: Mixed amphetamine salts (ADDERALL XR)
- Registration Number
- NCT00506727
- Lead Sponsor
- Shire
- Brief Summary
Evaluate the behavioral effects of ADDERALL XR versus STRATTERA under controlled conditions utilizing the SKAMP deportment scale.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 215
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adderall XR Mixed amphetamine salts (ADDERALL XR) - Atomoxetine hydrochloride Atomoxetine hydrochloride -
- Primary Outcome Measures
Name Time Method Change in SKAMP deportment scores from baseline to endpoint (averaged across Days 7, 14, 21) Approximately 3 weeks
- Secondary Outcome Measures
Name Time Method treatment-emergent adverse events approximately 3 weeks PERMP, SKAMP attention scale, CGI, CGIS-P, Peds QL Approximately 3 weeks
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States