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

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ClinicalTrials.gov Identifier: NCT00506727
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : March 5, 2015
Sponsor:
Information provided by:
Shire

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

Condition or disease Intervention/treatment Phase
ADHD Drug: Mixed amphetamine salts (ADDERALL XR) Drug: Atomoxetine hydrochloride Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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)
Study Start Date : August 2003
Actual Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Adderall XR Drug: Mixed amphetamine salts (ADDERALL XR)
Active Comparator: Atomoxetine hydrochloride Drug: Atomoxetine hydrochloride
Other Name: Strattera



Primary Outcome Measures :
  1. Change in SKAMP deportment scores from baseline to endpoint (averaged across Days 7, 14, 21) [ Time Frame: Approximately 3 weeks ]

Secondary Outcome Measures :
  1. PERMP, SKAMP attention scale, CGI, CGIS-P, Peds QL [ Time Frame: Approximately 3 weeks ]
  2. treatment-emergent adverse events [ Time Frame: approximately 3 weeks ]


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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506727


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

Additional Information:
Publications of Results:
ClinicalTrials.gov Identifier: NCT00506727     History of Changes
Other Study ID Numbers: SLI381-404
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: November 2007

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Atomoxetine Hydrochloride
Amphetamine
Adderall
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Central Nervous System Stimulants
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors