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

This study has been completed.

First Received: July 19, 2007 Last Updated: July 27, 2009 History of Changes

Sponsor:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00506727

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

Drug Information available for: Amphetamine

U.S. FDA Resources

Further study details as provided by Shire Pharmaceutical Development:

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

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 Pharmaceutical Development

Investigators

Study Director:

Garrick Fiddler, MD

Shire Pharmaceutical Development

More Information

Additional Information:

Synopsis of study results This link exits the ClinicalTrials.gov site

FDA-approved labelling information, US only This link exits the ClinicalTrials.gov site

FDA Recall information This link exits the ClinicalTrials.gov site

FDA Medical product safety alerts This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	SLI381-404
Study First Received:	July 19, 2007
Last Updated:	July 27, 2009
ClinicalTrials.gov Identifier:	NCT00506727 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity
Adderall
Mental Disorders
Therapeutic Uses
Physiological Effects of Drugs

Mental Disorders Diagnosed in Childhood
Attention Deficit and Disruptive Behavior Disorders
Central Nervous System Stimulants
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010