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

This study has been completed.

Sponsored by:	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

Drug Information available for: Atomoxetine Atomoxetine hydrochloride Sodium chloride Amphetamine Amphetamine sulfate Methamphetamine

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)

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 ]

Eligibility

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

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 of Results:

Study ID Numbers:	SLI381-404
Study First Received:	July 19, 2007
Last Updated:	November 30, 2007
ClinicalTrials.gov Identifier:	NCT00506727
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Methamphetamine
Attention Deficit Disorder with Hyperactivity
Adderall
Mental Disorders
Mental Disorders Diagnosed in Childhood

Atomoxetine
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Amphetamine

Additional relevant MeSH terms:

Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009