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

• Status: Completed
• Trial end date: 2004-07-02
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Adderall; Amphetamine; Atomoxetine Hydrochloride

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