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

Information source: Shire
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: ADHD

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

Phase: Phase 4

Status: Completed

Sponsored by: Shire

Official(s) and/or principal investigator(s):
Garrick Fiddler, MD, Study Director, Affiliation: Shire

Summary

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

Clinical Details

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)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Change in SKAMP deportment scores from baseline to endpoint (averaged across Days 7, 14, 21)

Secondary outcome:

PERMP, SKAMP attention scale, CGI, CGIS-P, Peds QL

treatment-emergent adverse events

Eligibility

Minimum age: 6 Years. Maximum age: 12 Years. Gender(s): Both.

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

Locations and Contacts

Massachusetts General Hospital, Boston, Massachusetts, United States
Additional Information

FDA-approved labelling information, US only

FDA Recall information

Starting date: August 2003
Last updated: March 4, 2015

Page last updated: August 23, 2015

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