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

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00506727
First received: July 19, 2007
Last updated: July 27, 2009
Last verified: November 2007
  Purpose

Evaluate the behavioral effects of ADDERALL XR versus STRATTERA under controlled conditions utilizing the SKAMP deportment scale.


Condition Intervention Phase
ADHD
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)

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
  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00506727

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

Additional Information:
Publications:
ClinicalTrials.gov 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:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Adderall
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014