Analog Classroom Study Comparison of ADDERALL XR With STRATTERA in Children Aged 6-12 With ADHD
This study has been completed.
Sponsor:
Shire Development LLC
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00506727
First received: July 19, 2007
Last updated: July 27, 2009
Last verified: November 2007
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Purpose
Evaluate the behavioral effects of ADDERALL XR versus STRATTERA under controlled conditions utilizing the SKAMP deportment scale.
| Condition | Intervention | Phase |
|---|---|---|
|
ADHD |
Drug: Mixed amphetamine salts (ADDERALL XR) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Drug Information available for:
Methamphetamine hydrochloride
Amphetamine sulfate
Amphetamine
Methamphetamine
Atomoxetine hydrochloride
Atomoxetine
Adderall
U.S. FDA Resources
Further study details as provided by Shire Development LLC:
Primary Outcome Measures:
- Change in SKAMP deportment scores from baseline to endpoint (averaged across Days 7, 14, 21) [ Time Frame: Approximately 3 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- PERMP, SKAMP attention scale, CGI, CGIS-P, Peds QL [ Time Frame: Approximately 3 weeks ] [ Designated as safety issue: No ]
- treatment-emergent adverse events [ Time Frame: approximately 3 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 215 |
| Study Start Date: | August 2003 |
| Study Completion Date: | August 2004 |
Eligibility| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00506727
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States | |
Sponsors and Collaborators
Shire Development LLC
Investigators
| Study Director: | Garrick Fiddler, MD | Shire Development LLC |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00506727 History of Changes |
| Other Study ID Numbers: | SLI381-404 |
| Study First Received: | July 19, 2007 |
| Last Updated: | July 27, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Amphetamine Methamphetamine Adderall Atomoxetine Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013