Analog Classroom Study Comparison of ADDERALL XR With STR... | NCT00506727

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

NCT00506727

Sponsor

Shire

Status

Completed

Last Update Posted

Jun 8, 2021Actual

Enrollment

215Actual

Phase

Phase 4

Conditions

ADHD

Interventions

Mixed amphetamine salts (ADDERALL XR)
Atomoxetine hydrochloride

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 5, 2003Actual

Primary Completion Date

Jul 2, 2004Actual

Completion Date

Jul 2, 2004Actual

First Submitted Date

Jul 19, 2007

First Submission Date that Met QC Criteria

Jul 23, 2007

First Posted Date

Jul 25, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2021

Last Update Posted Date

Jun 8, 2021Actual

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

215Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adderall XR	Experimental		Drug: Mixed amphetamine salts (ADDERALL XR)
Atomoxetine hydrochloride	Active Comparator		Drug: Atomoxetine hydrochloride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mixed amphetamine salts (ADDERALL XR)	Drug		Adderall XR
Atomoxetine hydrochloride

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in SKAMP deportment scores from baseline to endpoint (averaged across Days 7, 14, 21)		Approximately 3 weeks

Secondary Outcomes

Measure	Description	Time Frame
PERMP, SKAMP attention scale, CGI, CGIS-P, Peds QL		Approximately 3 weeks
treatment-emergent adverse events		approximately 3 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Study Director	Takeda	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts		United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16371674	Result	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.

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

ID	Term
C449521	SLI381
D000069445	Atomoxetine Hydrochloride

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals