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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