Analog Classroom Study Comparison of ADDERALL XR With STRATTERA in Children Aged 6-12 With ADHD
NCT ID: NCT00506727
Last Updated: 2021-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
215 participants
INTERVENTIONAL
2003-08-05
2004-07-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Adderall XR
Mixed amphetamine salts (ADDERALL XR)
Atomoxetine hydrochloride
Atomoxetine hydrochloride
Interventions
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Mixed amphetamine salts (ADDERALL XR)
Atomoxetine hydrochloride
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Capable of understanding and following classroom instructions
* Generally functioning academically at age-appropriate levels
Exclusion Criteria
* 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
6 Years
12 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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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.
Related Links
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FDA-approved labelling information, US only
FDA Recall information
Other Identifiers
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SLI381-404
Identifier Type: -
Identifier Source: org_study_id
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