The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in
adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).
Minimum age: 13 Years.
Maximum age: 17 Years.
Gender(s): Both.
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.
Schwerpunktpraxis fur Entwicklung und Lernen, Bamberg 96047, Germany
Klinik Fur Kinder- und Jugendpsychiatrie, Psychosomatik und Psychotherapie, Frankfurt 15236, Germany
Universitatsklinikum Freiburg, Freiburg 79104, Germany
Kinderarztpraxis Dr. Kaiser und Dr. MarineBe, Hamburg 22415, Germany
Zentralinstitut fur Seelische Gesundheit, Mannheim 68159, Germany
Medizinisches Studienzentrum Wurzburg, Wurzburg 97070, Germany
Vadaskert Gyermekpszichiatriai Korhaz es Szakambulancia, Budapest H-1021, Hungary
Bekes Megyei Pandy Kalman Korhaz, Gyula H-5700, Hungary
Pecsi Megyei Jogu varos Egyesitett Egeszsegugyi Intezmenyek, Pecs H-7632, Hungary
Szegedi Tudomanyegyetem, Szeged H-6725, Hungary
Gillbergcentrum, Goteborg 411 19, Sweden
PRIMA Barn-och Vuxenpsykiatri Jarva, Spanga 163 74, Sweden
Harmonex Neuroscience Research, Inc., Dothan, Alabama 36303, United States
Center for Advanced Improvement, Tucson, Arizona 85719, United States
Clinical Study Centers, LLC, Little Rock, Arkansas 72211, United States
Shanti Clinical Trials, Colton, California 92324, United States
Sun Valley Research Center, Imperial, California 92251, United States
Synergy Clinical Research Center, National City, California 91950, United States
Pacific Sleep Medicine, A Medical Corporation, Oceanside, California 92054, United States
Neuropsychiatric Research Center for Orange County, Orange, California 92868, United States
Peninsula Research Associates, Rolling Hills Estates, California 90274, United States
PCSD - Feighner Research, San Diego, California 92108, United States
University of California, San Francisco, San Francisco, California 94143, United States
Encompass Clinical Research, Spring Valley, California 91978, United States
Elite Clinical Trials, Wildomar, California 92595, United States
IMMUNOe International Research Center, Centennial, Colorado 80112, United States
MCB Clinical Research Centers, LLC, Colorado Springs, Colorado 80910, United States
Coastal Connecticut Research, LLC, New London, Connecticut 06320, United States
Florida Clinical Research Center, LLC, Bradenton, Florida 34201, United States
Amedica Research Institute, Inc, Hialeah, Florida 33013, United States
Clinical Neuroscience Solutions, Inc, Jacksonville, Florida 32256, United States
Sarkis Clinical Trials, Lake City, Florida 32055, United States
Florida Clinical Research Center, LLC, Maitland, Florida 32751, United States
Prevention & Strengthening Solutions, Inc., Miami, Florida 33169, United States
Scientific Clinical Research, Inc., North Miami, Florida 33161, United States
Medical Research Group of Central Florida, Orange City, Florida 32763, United States
Clinical Neuroscience Solutions, Inc., Orlando, Florida 32806, United States
Compass Research, LLC, Orlando, Florida 32806, United States
Miami Research Associates, South Miami, Florida 33143, United States
Stedman Clinical Trials, Tampa, Florida 33613, United States
Atlanta Institute of Medicine & Research, Inc, Atlanta, Georgia 30328, United States
Clinical Research Center, University of Illinois at Chicago, Chicago, Illinois 60608, United States
Capstone Clinical Research, Libertyville, Illinois 60048, United States
Baber Research Group, Naperville, Illinois 60563, United States
Pedia Research, LLC, Newburgh, Indiana 47630, United States
Psychiatric Associates, Overland Park, Kansas 66211, United States
Pedia Research, LLC, Owensboro, Kentucky 42301, United States
Louisiana Resarch Associates, Inc., New Orleans, Louisiana 70114, United States
Marc Hertzman, MD, PC, Rockville, Maryland 20852, United States
Rochester Center for Behavioral Medicine, Rochester Hills, Michigan 48307, United States
Clinical Neurophysiology Services, PC, Sterling Heights, Michigan 48314, United States
Behavioral Medical Center - Troy, Troy, Michigan 48083, United States
Comprehensive Psychiatric Associates, Gladstone, Missouri 64118, United States
Psychiatric Care & Research Center, O'Fallon, Missouri 63368, United States
St. Charles Psychiatric Associates - Midwest Research Group, St. Charles, Missouri 63301, United States
Premier Psychiatric Research Institute, LLC, Lincoln, Nebraska 68526, United States
University of Nebraska Medical Center Dept Of Psychiatry, Omaha, Nebraska 68198, United States
Center for Psychiatry & Behavioral Medicine, Inc., Las Vegas, Nevada 89128, United States
Center for Emotional Fitness, Cherry Hill, New Jersey 08002, United States
The NeuroCognitive Institute, Mt. Arlington, New Jersey 07856, United States
Albuquerque Neuroscience, Inc., Albuquerque, New Mexico 87109, United States
Brain Resource Center, New York, New York 10023, United States
Mount Sinai School of Medicine/Dept of Psychiaatry, New York, New York 10029, United States
Duke University medical Center/ Duke ADHD Program, Durham, North Carolina 27705, United States
PMG Research of Wilmington, Wilmington, North Carolina 28401, United States
True North Clinical Research, Kentville, Nova Scotia B4N 4K9, Canada
University of Cincinnati College of Medicine/UCPC, Cincinnati, Ohio 45219, United States
The Ohio State University Nisonger Center, Columbus, Ohio 43210, United States
Tulsa Clinical Research, LLC, Tulsa, Oklahoma 74104, United States
The Kids Clinic, Whitby, Ontario L1N 2L1, Canada
Cyn3rgy Research, Gresham, Oregon 97030, United States
Oregon Center for Clinical Investigations Inc, Portland, Oregon 97210, United States
Summit Research Network, Portland, Oregon 97210, United States
Oregon Center for Clinical Investigations, Inc, Salem, Oregon 97301, United States
University Services, West Chester, Pennsylvania 19380, United States
Omega Medical Research, Warwick, Rhode Island 02886, United States
Rainbow Research, Inc., Barnwell, South Carolina 29812, United States
Clinical Neuroscience Solutions, Inc., Memphis, Tennessee 38119, United States
FutureSearch Trials of Dallas, LP, Dallas, Texas 75231, United States
Research Across America/Psychiatric Medical Associates, Dallas, Texas 75234, United States
Bayou City Research, Houston, Texas 77007, United States
Claghorn-Lesem Research Clinic, Ltd., Houston, Texas 77008, United States
Clinical Trial Network, Houston, Texas 77074, United States
Houston Clinical Trials, LLC, Houston, Texas 77098, United States
Red Oak Psychiatry Associates, PA, Houston, Texas 77090, United States
Texas Center for Drug Development, Inc., Houston, Texas 77081, United States
Westex Clinical Investigations, Lubbock, Texas 79423, United States
Clinical Trials of Texas, Inc., San Antonio, Texas 78229, United States
Univ of Texas Health Science Center at San Antonio, San Antonio, Texas 78229, United States
Ericksen Research and Development - Westside Medical, Clinton, Utah 84015, United States
University of Virginia Child and Family Psychiatry Clinic, Charlottesville, Virginia 22903, United States
Northwest Clinical Research Center, Bellevue, Washington 98007, United States
Eastside Thereapeutic Resource, Kirkland, Washington 98033, United States
Summit Research Network (Seattle), LLC, Seattle, Washington 98104, United States
Rockwood Clinic, P.S., Spokane, Washington 99202, United States