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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: July 27, 2009
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)
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)

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

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: July 27, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Central Nervous System Agents
Central Nervous System Stimulants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on March 03, 2015