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

Shire

Status and phase: Completed; Phase 4

Conditions: ADHD

Treatments: Drug: Mixed amphetamine salts (ADDERALL XR); Drug: Atomoxetine hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00506727

SLI381-404

Details and patient eligibility

About

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

Enrollment: 215 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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215 participants in 2 patient groups

Adderall XR

Experimental group

Treatment:

Drug: Mixed amphetamine salts (ADDERALL XR)

Atomoxetine hydrochloride

Active Comparator group

Treatment:

Drug: Atomoxetine hydrochloride

Sponsor of this trial

Lead Sponsor

Shire