Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder

Phase 4

Completed

Conditions: Attention-deficit/Hyperactivity Disorder

Interventions: Drug: Methylphenidate Hydrochloride
Drug: Placebo
Drug: Lisdexamfetamine dimesylate

Registration Number: NCT01552902

Lead Sponsor: Shire

Brief Summary: The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 549

Inclusion Criteria

Subject must be 13-17 years of age, inclusive, at the time of consent.
Subject must weigh more than 79.5lb.
The parent/LAR must be available at approximately 7:00AM (±2 hours) to dispense the dose of investigational product for the study duration.
Subject, who is a female, must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test and a negative urine pregnancy test and agree to comply with any applicable contraceptive requirements of the protocol.
Subject has an ADHD-RS-IV total score ≥28.
Subject is able to swallow a capsule.
Subject does not have hypertension and has a resting sitting blood pressure less than or equal to 135/85mmHg.

Exclusion Criteria

Subject has a current, controlled (with medications prohibited in this study) or uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any significant comorbid Axis II disorder or significant Axis I disorder (such as post traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, depressive or anxiety disorder.
Diagnosis of conduct disorder. Oppositional defiant disorder is not exclusionary.
Subject is considered a suicide risk, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded.
Subject is underweight or overweight.
Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or an infectious process requiring antibiotics), disability, or other condition. Mild, stable asthma is not exclusionary.
Subject has a history of seizures (other than infantile febrile seizures), a chronic or current tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder.
Subject has a known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place him/her at increased vulnerability to the sympathomimetic effects of a stimulant medication.
Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
Subject has any clinically significant ECG or clinically significant laboratory abnormality.
Subject has current abnormal thyroid function, defined as abnormal thyroid stimulating hormone (TSH) and thyroxine (T4). Treatment with a stable dose of thyroid medication for at least 3 months is permitted.
Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product.
Subject has a documented allergy, hypersensitivity, or intolerance to MPH or to any excipients in the reference product.
Subject has failed to fully respond to an adequate course(s) (dose and duration) of MPH or amphetamine therapy.
Subject has a history of suspected substance abuse or dependence disorder (excluding nicotine). Subjects with a lifetime history of amphetamine, cocaine, or other stimulant abuse and/or dependence will be excluded.
Subject has a positive urine drug result.
Subject has previously participated in this study or another clinical study involving SPD489/NRP104.
Subject has glaucoma.
Subject is required to take or anticipates the need to take medications that have CNS effects or affect performance, such as sedating antihistamines and decongestant sympathomimetics, or are monoamine oxidase inhibitors. Stable use of bronchodilator inhalers is not exclusionary.
Subject is female and is pregnant or lactating.
Subject is well controlled on his/her current ADHD medication.
Subject has a pre-existing severe gastrointestinal tract narrowing.

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	-
Placebo	Placebo	-
Lisdexamfetamine dimesylate	Lisdexamfetamine dimesylate	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 6	Baseline, Week 6	The ADHD-RS-IV was developed to measure the behaviors of children with ADHD and is commonly used in clinical studies of ADHD. The ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54, Higher score = more severe symptoms.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With an Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 6	Week 6	The Clinical Global Impressions Scale permits a global evaluation of the participant's severity of illness and improvement over time. The scale included a severity of illness item and a global improvement item. The investigator performed the CGI-I to rate the improvement of a participant's ADHD symptoms based on a 7-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse.). Percentage of participants with an improved measurement (response of very much improved and much improved) is reported.

Trial Locations

Locations (92): Center for Advanced Improvement
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Tucson, Arizona, United States
Clinical Study Centers, LLC
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Little Rock, Arkansas, United States
Coastal Connecticut Research, LLC
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New London, Connecticut, United States
Clinical Neuroscience Solutions, Inc.
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Memphis, Tennessee, United States
Center for Emotional Fitness
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Cherry Hill, New Jersey, United States
True North Clinical Research
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Kentville, Nova Scotia, Canada
Pecsi Megyei Jogu varos Egyesitett Egeszsegugyi Intezmenyek
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Pecs, Hungary
The Ohio State University Nisonger Center
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Columbus, Ohio, United States
Clinical Research Center, University of Illinois at Chicago
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Chicago, Illinois, United States
Center for Psychiatry & Behavioral Medicine, Inc.
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Las Vegas, Nevada, United States
Duke University medical Center/ Duke ADHD Program
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Durham, North Carolina, United States
University of Cincinnati College of Medicine/UCPC
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Cincinnati, Ohio, United States
Univ of Texas Health Science Center at San Antonio
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San Antonio, Texas, United States
Peninsula Research Associates
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Rolling Hills Estates, California, United States
PCSD - Feighner Research
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San Diego, California, United States
Encompass Clinical Research
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Spring Valley, California, United States
MCB Clinical Research Centers, LLC
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Colorado Springs, Colorado, United States
IMMUNOe International Research Center
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Centennial, Colorado, United States
Florida Clinical Research Center, LLC
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Maitland, Florida, United States
Amedica Research Institute, Inc
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Hialeah, Florida, United States
Sarkis Clinical Trials
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Lake City, Florida, United States
Clinical Neuroscience Solutions, Inc
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Jacksonville, Florida, United States
Scientific Clinical Research, Inc.
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North Miami, Florida, United States
Miami Research Associates
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South Miami, Florida, United States
Pedia Research, LLC
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Owensboro, Kentucky, United States
Atlanta Institute of Medicine & Research, Inc
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Atlanta, Georgia, United States
Capstone Clinical Research
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Libertyville, Illinois, United States
Baber Research Group
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Naperville, Illinois, United States
Marc Hertzman, MD, PC
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Rockville, Maryland, United States
Rochester Center for Behavioral Medicine
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Rochester Hills, Michigan, United States
Clinical Neurophysiology Services, PC
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Sterling Heights, Michigan, United States
Behavioral Medical Center - Troy
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Troy, Michigan, United States
Comprehensive Psychiatric Associates
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Gladstone, Missouri, United States
St. Charles Psychiatric Associates - Midwest Research Group
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Saint Charles, Missouri, United States
Psychiatric Care & Research Center
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O'Fallon, Missouri, United States
Premier Psychiatric Research Institute, LLC
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Lincoln, Nebraska, United States
Mount Sinai School of Medicine/Dept of Psychiaatry
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New York, New York, United States
The NeuroCognitive Institute
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Mount Arlington, New Jersey, United States
PMG Research of Wilmington
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Wilmington, North Carolina, United States
Brain Resource Center
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New York, New York, United States
Tulsa Clinical Research, LLC
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Tulsa, Oklahoma, United States
Cyn3rgy Research
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Gresham, Oregon, United States
Oregon Center for Clinical Investigations, Inc
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Salem, Oregon, United States
University Services
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West Chester, Pennsylvania, United States
FutureSearch Trials of Dallas, LP
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Dallas, Texas, United States
Rainbow Research, Inc.
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Barnwell, South Carolina, United States
Bayou City Research
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Houston, Texas, United States
Texas Center for Drug Development, Inc.
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Houston, Texas, United States
Claghorn-Lesem Research Clinic, Ltd.
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Houston, Texas, United States
Red Oak Psychiatry Associates, PA
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Houston, Texas, United States
Houston Clinical Trials, LLC
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Houston, Texas, United States
Westex Clinical Investigations
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Lubbock, Texas, United States
Clinical Trials of Texas, Inc.
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San Antonio, Texas, United States
Ericksen Research and Development - Westside Medical
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Clinton, Utah, United States
Northwest Clinical Research Center
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Bellevue, Washington, United States
University of Virginia Child and Family Psychiatry Clinic
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Charlottesville, Virginia, United States
Eastside Thereapeutic Resource
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Kirkland, Washington, United States
Rockwood Clinic, P.S.
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Spokane, Washington, United States
Summit Research Network (Seattle), LLC
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Seattle, Washington, United States
The Kids Clinic
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Whitby, Ontario, Canada
Klinik Fur Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie
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Frankfurt, Germany
Schwerpunktpraxis fur Entwicklung und Lernen
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Bamberg, Germany
Universitatsklinikum Freiburg
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Freiburg, Germany
Kinderarztpraxis Dr. Kaiser und Dr. MarineBe
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Hamburg, Germany
Zentralinstitut fur Seelische Gesundheit
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Mannheim, Germany
Bekes Megyei Pandy Kalman Korhaz
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Gyula, Hungary
Medizinisches Studienzentrum Wurzburg
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Wurzburg, Germany
Szegedi Tudomanyegyetem
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Szeged, Hungary
Vadaskert Gyermekpszichiatriai Korhaz es Szakambulancia
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Budapest, Hungary
Gillbergcentrum
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Goteborg, Sweden
PRIMA Barn-och Vuxenpsykiatri Jarva
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Spanga, Sweden
Psychiatric Associates
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Overland Park, Kansas, United States
Sun Valley Research Center
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Imperial, California, United States
Shanti Clinical Trials
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Colton, California, United States
Pacific Sleep Medicine, A Medical Corporation
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Oceanside, California, United States
Harmonex Neuroscience Research, Inc.
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Dothan, Alabama, United States
Neuropsychiatric Research Center for Orange County
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Orange, California, United States
Medical Research Group of Central Florida
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Orange City, Florida, United States
Prevention & Strengthening Solutions, Inc.
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Miami, Florida, United States
Synergy Clinical Research Center
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National City, California, United States
Elite Clinical Trials
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Wildomar, California, United States
Omega Medical Research
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Warwick, Rhode Island, United States
Research Across America/Psychiatric Medical Associates
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Dallas, Texas, United States
Clinical Trial Network
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Houston, Texas, United States
Compass Research, LLC
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Orlando, Florida, United States
University of Nebraska Medical Center Dept Of Psychiatry
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Omaha, Nebraska, United States
Stedman Clinical Trials
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Tampa, Florida, United States
University of California, San Francisco
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San Francisco, California, United States
Oregon Center for Clinical Investigations Inc
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Portland, Oregon, United States
Summit Research Network
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Portland, Oregon, United States
Louisiana Resarch Associates, Inc.
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New Orleans, Louisiana, United States
Albuquerque Neuroscience, Inc.
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Albuquerque, New Mexico, United States