Analog Classroom Study Comparison of ADDERALL XR With STRATTERA in Children Aged 6-12 With ADHD
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)
1 other identifier
interventional
215
1 country
1
Brief Summary
Evaluate the behavioral effects of ADDERALL XR versus STRATTERA under controlled conditions utilizing the SKAMP deportment scale.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2003
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 5, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2004
CompletedFirst Submitted
Initial submission to the registry
July 19, 2007
CompletedFirst Posted
Study publicly available on registry
July 25, 2007
CompletedJune 8, 2021
June 1, 2021
11 months
July 19, 2007
June 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in SKAMP deportment scores from baseline to endpoint (averaged across Days 7, 14, 21)
Approximately 3 weeks
Secondary Outcomes (2)
PERMP, SKAMP attention scale, CGI, CGIS-P, Peds QL
Approximately 3 weeks
treatment-emergent adverse events
approximately 3 weeks
Study Arms (2)
Adderall XR
EXPERIMENTALAtomoxetine hydrochloride
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, United States
Related Publications (1)
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. doi: 10.1177/1087054705281121.
PMID: 16371674RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2007
First Posted
July 25, 2007
Study Start
August 5, 2003
Primary Completion
July 2, 2004
Study Completion
July 2, 2004
Last Updated
June 8, 2021
Record last verified: 2021-06