Analog Classroom Study Comparison of ADDERALL XR With STRATTERA in Children Aged 6-12 With ADHD
Information source: Shire Pharmaceutical Development
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: ADHD
Intervention: Mixed amphetamine salts (ADDERALL XR) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Shire Pharmaceutical Development Official(s) and/or principal investigator(s):
Garrick Fiddler, MD, Study Director, Affiliation: Shire Pharmaceutical Development
Summary
Evaluate the behavioral effects of ADDERALL XR versus STRATTERA under controlled conditions
utilizing the SKAMP deportment scale.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in SKAMP deportment scores from baseline to endpoint (averaged across Days 7, 14, 21)
Secondary outcome: PERMP, SKAMP attention scale, CGI, CGIS-P, Peds QLtreatment-emergent adverse events
Eligibility
Minimum age: 6 Years.
Maximum age: 12 Years.
Gender(s): Both.
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
Locations and Contacts
Massachusetts General Hospital, Boston, Massachusetts, United States
Additional Information
Synopsis of study results FDA-approved labelling information, US only FDA Recall information FDA Medical product safety alerts
Starting date: August 2003
Ending date: August 2004
Last updated: November 30, 2007
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