Analog Classroom Study Comparison of ADDERALL XR With STRATTERA in Children Aged 6-12 With ADHD

This study has been completed.
Information provided by:
Shire Identifier:
First received: July 19, 2007
Last updated: March 4, 2015
Last verified: November 2007
Evaluate the behavioral effects of ADDERALL XR versus STRATTERA under controlled conditions utilizing the SKAMP deportment scale.

Condition Intervention Phase
Drug: Mixed amphetamine salts (ADDERALL XR)
Drug: Atomoxetine hydrochloride
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by Shire:

Primary Outcome Measures:
  • Change in SKAMP deportment scores from baseline to endpoint (averaged across Days 7, 14, 21) [ Time Frame: Approximately 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PERMP, SKAMP attention scale, CGI, CGIS-P, Peds QL [ Time Frame: Approximately 3 weeks ] [ Designated as safety issue: No ]
  • treatment-emergent adverse events [ Time Frame: approximately 3 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 215
Study Start Date: August 2003
Study Completion Date: August 2004
Arms Assigned Interventions
Experimental: Adderall XR Drug: Mixed amphetamine salts (ADDERALL XR)
Active Comparator: Atomoxetine hydrochloride Drug: Atomoxetine hydrochloride
Other Name: Strattera


Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts 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
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Please refer to this study by its identifier: NCT00506727

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States
Sponsors and Collaborators
Study Director: Garrick Fiddler, MD Shire
  More Information

Additional Information:
Publications: Identifier: NCT00506727     History of Changes
Other Study ID Numbers: SLI381-404 
Study First Received: July 19, 2007
Last Updated: March 4, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders
Neurodevelopmental Disorders
Atomoxetine Hydrochloride
Adrenergic Agents
Adrenergic Uptake Inhibitors
Central Nervous System Stimulants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs processed this record on May 24, 2016