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

ADHD Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00506727
• Other study ID #: SLI381-404
• Status: Completed
• Phase: Phase 4
• Start date: August 5, 2003
• Est. completion date: July 2, 2004

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: July 2, 2004
• Est. primary completion date: July 2, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD

Intervention

Drug:
• Mixed amphetamine salts (ADDERALL XR)

• Atomoxetine hydrochloride

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

References & 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 s — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in SKAMP deportment scores from baseline to endpoint (averaged across Days 7, 14, 21)		Approximately 3 weeks
Secondary	PERMP, SKAMP attention scale, CGI, CGIS-P, Peds QL		Approximately 3 weeks
Secondary	treatment-emergent adverse events		approximately 3 weeks

External Links

•   FDA Recall information
•   FDA-approved labelling information, US only