Phase
Condition
Williams Syndrome
Attention Deficit/hyperactivity Disorder (Adhd - Adults)
Treatment
Concerta
Adhansia XR
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients with a physician-confirmed diagnosis of ADHD per Diagnostic and StatisticalManual of Mental Disorders (DSM-5) criteria and the health care practitioner (HCP) hasmade the decision to prescribe an extended-release methylphenidate (ER MPH) product tothe patient for potential improvement of symptoms throughout and later in the day,independent of this study.
- Patient must be 12 years of age or older.
- Patient must be eligible to receive Adhansia XR or osmotic- release oral deliverysystem methylphenidate ([OROS MPH] or Concerta) according to the US product labels; apatient must be eligible and willing to receive either drug, as randomization willassign them to a specific treatment group. Patient may be treatment-experienced ornaïve to pharmacological therapy for ADHD, so long as all inclusion and no exclusioncriteria are met.
- Patient must be willing to take only the assigned study medication per HCPinstructions based on FDA label guidance for treatment of their ADHD for the first 2months of the study (i.e. full titration period). Patients should not be on any othermedication, or starting any new non-medication treatment, proven to have effect onADHD in the first two months of the study.
Exclusion
Exclusion Criteria:
- Concurrent participation in an investigational study in which patient assessmentand/or treatment may be dictated by a protocol.
- Patients with a true allergy to methylphenidate (MPH), amphetamine (AMP), orsympathomimetic amines, history of serious adverse reactions to MPH or AMP or be knownto be non-responsive to MPH or AMP treatment.
- Patient is currently stable on their ADHD treatment regimen.
- Female patients of child bearing potential who are pregnant, planning on becomingpregnant or breastfeeding.
- Patient with any known conditions that are contraindicated for either Adhansia XR orOROS MPH (or Concerta) use, as documented in the US Full Prescribing Information,including patients with any known serious structural cardiac abnormalities,cardiomyopathy, serious heart arrhythmias, or coronary artery disease.
- Patients with a known sensitivity to the food dye tartrazine (Federal Food, Drug, andCosmetic Yellow No. 5).
- Suicidal Ideation
- The Columbia-Suicide Severity Rating Scale (C-SSRS) will be administered atscreening and at Month-2, Month-4, and Month-6, but also depends on the judgmentof the HCP.
- Inability or unwillingness of the patient (or parent/guardian if patient is a minor)to complete the study-required electronic questionnaires and provide requiredinformation through electronic means.
Study Design
Study Description
Connect with a study center
Harmonex, Inc.
Dothan, Alabama 36303
United StatesSite Not Available
Southern California Research LLC
Beverly Hills, California 90210
United StatesSite Not Available
CT Clinical Research
Cromwell, Connecticut 06416
United StatesSite Not Available
Gulfcoast Clinical Research Center
Fort Myers, Florida 33912
United StatesSite Not Available
Eastern Research. Inc.
Hialeah, Florida 33013
United StatesSite Not Available
Reliable Clinical Research, LLC
Hialeah, Florida 33012
United StatesSite Not Available
Wellness Research Center Inc.
Miami, Florida 33135
United StatesSite Not Available
AdventHealth Medical Group Pediatrics at Orange City
Orange City, Florida 32763
United StatesSite Not Available
Pediatric Epilepsy & Neurology Specialists
Tampa, Florida 33609
United StatesSite Not Available
Clinical Integrative Research Center of Atlanta
Atlanta, Georgia 30328
United StatesSite Not Available
Revive Research Institute
Elgin, Illinois 60123
United StatesSite Not Available
AMR-Baber Research Inc.
Naperville, Illinois 60563
United StatesSite Not Available
BTC of New Bedford, LLC
New Bedford, Massachusetts 02740
United StatesSite Not Available
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan 48302
United StatesSite Not Available
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan 48307
United StatesSite Not Available
Psychiatric Care and Research Center
O'Fallon, Missouri 63368
United StatesSite Not Available
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri 63304
United StatesSite Not Available
Clinical Research of Southern Nevada, LLC
Las Vegas, Nevada 89128
United StatesSite Not Available
Center for Emotional Fitness
Cherry Hill, New Jersey 08002
United StatesSite Not Available
Bioscience Research, LLC
Mount Kisco, New York 10549
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
Richmond Behavioral Associates
Staten Island, New York 10312
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27705
United StatesSite Not Available
Mid-Ohio Behavioral Health
Columbus, Ohio 43205
United StatesSite Not Available
SFM Clinical Trials
Scotland, Pennsylvania 17254
United StatesSite Not Available
Rainbow Research
Barnwell, South Carolina 29812
United StatesSite Not Available
FutureSearch Trials of Dallas, LP
Dallas, Texas 75231
United StatesSite Not Available
InSite Clinical Research, LLC
DeSoto, Texas 75115
United StatesSite Not Available
Red Oak Psychiatry Associates, PA
Houston, Texas 77090
United StatesSite Not Available
Road Runner Research, Ltd.
San Antonio, Texas 78249
United StatesSite Not Available
Family Psychiatry of the Woodlands
The Woodlands, Texas 77381
United StatesSite Not Available
Dixie Pediatrics
Saint George, Utah 84790
United StatesSite Not Available
Clinical Research Partners, LLC
Petersburg, Virginia 23805
United StatesSite Not Available
Eastside Therapeutic Resource Inc dba Core Clinical Research
Everett, Washington 98201
United StatesSite Not Available
MultiCare Health System - Rockwood Clinic
Spokane, Washington 99202
United StatesSite Not Available
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