Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Interventions
- Registration Number
- NCT01552915
- 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
- 464
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Lisdexamfetamine Dimesylate Lisdexamfetamine dimesylate - Methylphenidate Hydrochloride Methylphenidate Hydrochloride -
- 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 8 Baseline and week 8 The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. Higher score indicates more severe symptoms.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment Baseline and up to 8 Weeks Change From Baseline in Pulse Rate at up to 8 Weeks - Last on Treatment Assessment Baseline and up to 8 weeks Percentage of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 8 - Last Observation Carried Forward (LOCF) Week 8 Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Change From Baseline in Diastolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment Baseline and up to 8 weeks
Trial Locations
- Locations (77)
Amedica Research Institute
🇺🇸Hialeah, Florida, United States
Pacific Clinical Research Medical Group
🇺🇸Orange, California, United States
Fidelity Clinical Research, Inc.
🇺🇸Lauderhill, Florida, United States
SDS Clinical Trials, Inc.
🇺🇸Orange, California, United States
AMR Baber Research Group, Inc.
🇺🇸Naperville, Illinois, United States
Atlanta Institute of Medicine and Research
🇺🇸Atlanta, Georgia, United States
Four Rivers Clinical Research
🇺🇸Paducah, Kentucky, United States
Florida Clinical Research Center, LLC
🇺🇸Maitland, Florida, United States
American Medical Research, Inc
🇺🇸Oak Brook, Illinois, United States
Neuroscientific InSights
🇺🇸Rockville, Maryland, United States
Neuropsychiatric Research Center of Orange County
🇺🇸Santa Ana, California, United States
Janus Center for Psychiatric Research
🇺🇸West Palm Beach, Florida, United States
Advocate Hope Children's Hospital
🇺🇸Oak Lawn, Illinois, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Synergy Clinical Research Center
🇺🇸National City, California, United States
Clinical Study Centers, LLC
🇺🇸Little Rock, Arkansas, United States
Peninsula Research Associates, Inc.
🇺🇸Rolling Hills Estates, California, United States
Elite Clinical Trials
🇺🇸Wildomar, California, United States
Capstone Clinical Research
🇺🇸Libertyville, Illinois, United States
AMR Conventions Research
🇺🇸Naperville, Illinois, United States
Marc Hertzman MD, PC
🇺🇸Rockville, Maryland, United States
Rochester Center for Behavioral Medicine
🇺🇸Rochester Hills, Michigan, United States
Comprehensive Psychiatric Associates
🇺🇸Gladstone, Missouri, United States
St Charles Psychiatric Associates
🇺🇸Saint Charles, Missouri, United States
Premier Psychiatric Research Institute
🇺🇸Lincoln, Nebraska, United States
CRCNJ - Clinical Research Center of New Jersey
🇺🇸Gibbsboro, New Jersey, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
North Coast Clinical Trials
🇺🇸Beachwood, Ohio, United States
Innovis Health, LLC
🇺🇸Fargo, North Dakota, United States
The Ohio State University Nisonger Center
🇺🇸Columbus, Ohio, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Professional Psychiatric Services
🇺🇸Mason, Ohio, United States
Family Practice of Wadsworth, Inc.
🇺🇸Wadsworth, Ohio, United States
Oregon Center for Clinical Investigations, Inc.
🇺🇸Salem, Oregon, United States
R/D Clinical Research, Inc.
🇺🇸Lake Jackson, Texas, United States
Westex Clinical Investigations
🇺🇸Lubbock, Texas, United States
Wharton Research Center, Inc.
🇺🇸Wharton, Texas, United States
NeuroScience, Inc.
🇺🇸Herndon, Virginia, United States
University of Virginia Child and Family Psychiatry Clinical
🇺🇸Charlottesville, Virginia, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Eastside Therapeutic Resource
🇺🇸Kirkland, Washington, United States
Rockwood Clinic, P.S.
🇺🇸Spokane, Washington, United States
Claghorn-Lesem Reseach Clinic, Ltd.
🇺🇸Houston, Texas, United States
Texas Center for Drug Development, Inc.
🇺🇸Houston, Texas, United States
Red Oak Psychiatry Associates, PA
🇺🇸Houston, Texas, United States
Summit Research Network (Seattle), LLC
🇺🇸Seattle, Washington, United States
PCSD - Feighner Research
🇺🇸San Diego, California, United States
Scientific Clinical Research, Inc.
🇺🇸Miami, Florida, United States
Center for Psychiatry and Behavioral Medicine, Inc.
🇺🇸Las Vegas, Nevada, United States
University of Cincinnati Dept. of Psychiatry & Behavioral
🇺🇸Cincinnati, Ohio, United States
Duke Child and Family Study Center
🇺🇸Durham, North Carolina, United States
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, United States
University of Texas HSC at San Antonio Dept. of Psychiatry
🇺🇸San Antonio, Texas, United States
Psychiatric & Behavioral Solutions
🇺🇸Salt Lake City, Utah, United States
Psychiatric Associates
🇺🇸Overland Park, Kansas, United States
MCB Clinical Research Centers, LLC
🇺🇸Colorado Springs, Colorado, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Behavioral Medical Center - Troy
🇺🇸Troy, Michigan, United States
Cyn3rgy Research
🇺🇸Gresham, Oregon, United States
Coastal Carolina Research Center
🇺🇸Mount Pleasant, South Carolina, United States
Research Strategies of Memphis, LLC
🇺🇸Memphis, Tennessee, United States
Clinical Neurophysiology Services, PC
🇺🇸Sterling Heights, Michigan, United States
Melmed Center
🇺🇸Scottsdale, Arizona, United States
Precise Research Centers
🇺🇸Flowood, Mississippi, United States
Center for Emotional Fitness
🇺🇸Cherry Hill, New Jersey, United States
Neurcognitive Institute
🇺🇸Mount Arlington, New Jersey, United States
Neuroscience Research Institute, Inc
🇺🇸Oak Park, Illinois, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Orlando, Florida, United States
Compass Research, LLC
🇺🇸Orlando, Florida, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
Oregon Center for Clinical Investigations, Inc. (OCCI, Inc.)
🇺🇸Portland, Oregon, United States
Summit Research Network (Oregon) Inc.
🇺🇸Portland, Oregon, United States
Carolina Clinical Trials, Inc.
🇺🇸Charleston, South Carolina, United States
FutureSearch Trials
🇺🇸Austin, Texas, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States