Analog Classroom Study Comparison of ADDERALL XR With STRATTERA in Children Aged 6-12 With ADHD
Overview
Evaluate the behavioral effects of ADDERALL XR versus STRATTERA under controlled conditions utilizing the SKAMP deportment scale.
Full Title of Study: “A Randomized, Double-Blind, Parallel-Group, Analog Classroom Study, Evaluating ADDERALL XR Versus STRATTERA, Dosed Once Daily, in Children Aged 6-12 With Attention Deficit Hyperactivity Disorder (ADHD)”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double
- Study Primary Completion Date: July 2, 2004
Interventions
- Drug: Mixed amphetamine salts (ADDERALL XR)
- Drug: Atomoxetine hydrochloride
Arms, Groups and Cohorts
- Experimental: Adderall XR
- Active Comparator: Atomoxetine hydrochloride
Clinical Trial Outcome Measures
Primary Measures
- Change in SKAMP deportment scores from baseline to endpoint (averaged across Days 7, 14, 21)
- Time Frame: Approximately 3 weeks
Secondary Measures
- PERMP, SKAMP attention scale, CGI, CGIS-P, Peds QL
- Time Frame: Approximately 3 weeks
- treatment-emergent adverse events
- Time Frame: approximately 3 weeks
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 6 Years
Maximum Age: 12 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Shire
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Study Director, Study Director, Takeda
Citations Reporting on Results
Wigal SB, McGough JJ, McCracken JT, Biederman J, Spencer TJ, Posner KL, Wigal TL, Kollins SH, Clark TM, Mays DA, Zhang Y, Tulloch SJ. A laboratory school comparison of mixed amphetamine salts extended release (Adderall XR) and atomoxetine (Strattera) in school-aged children with attention deficit/hyperactivity disorder. J Atten Disord. 2005 Aug;9(1):275-89. doi: 10.1177/1087054705281121.
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