Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD
- Conditions
- Attention Deficit Hyperactivity Disorder (ADHD)
- Interventions
- Registration Number
- NCT00500071
- Lead Sponsor
- Shire
- Brief Summary
Assess the efficacy \& tolerability of Vyvanse when children aged 6-12 years diagnosed with ADHD are dosed to optimal effect.
- Detailed Description
Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (lisdexamfetamine dimesylate) in Children aged 6-12 Diagnosed with ADHD
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 318
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Vyvanse (lisdexamfetamine dimesylate) -
- Primary Outcome Measures
Name Time Method Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks Baseline and 7 weeks Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. 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.
- Secondary Outcome Measures
Name Time Method Weekly Change From Baseline in Total ADHD-RS-IV Score Baseline and 1, 2, 3, 4, 5, 6, and 7 weeks Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. 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.
Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at 7 Weeks Baseline and 7 weeks Behavior Rating Inventory of Executive Function (BRIEF) is an 86-item questionnaire composed of three scales (Global Executive Composite, Behavioral Recognition Index, and Metacognition Index). Items are rated 1 (never), 2 (sometimes), and 3 (often). Lower scores reflect better functioning.
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) 7 weeks 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 or 2 on the scale.
Number of Participants With Improvement onParent Global Assessment (PGA) 7 weeks Parent Global Assessment (PGA) 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 Expression and Emotional Scale for Children (EESC) Scores at 7 Weeks Baseline and 7 weeks Expression and Emotional Scale for Children (EESC) consists of 29 items rated on a scale from 1 (not true at all) to 5 (very much true). Lower scores reflect better emotional outcomes.
Trial Locations
- Locations (39)
Children's Development Center
🇺🇸Winter Park, Florida, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
Melmed Center
🇺🇸Scottsdale, Arizona, United States
Miami Research Associates
🇺🇸Miami, Florida, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
ADHD Program, Western Psychiatric Institute and Clinic
🇺🇸Pittsburgh, Pennsylvania, United States
UCSF-Langely Porter Psych Institute
🇺🇸San Francisco, California, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
CNS Research Institute, Inc
🇺🇸Jacksonville, Florida, United States
Valley Clinical Research
🇺🇸El Centro, California, United States
Peninsula Research Assoc, Inc
🇺🇸Rolling Hills Estates, California, United States
Shire Clinical Research Site
🇺🇸Oklahoma City, Oklahoma, United States
CORE Research, Inc
🇺🇸Maitland, Florida, United States
Clinical Neuroscience Solutions, Inc
🇺🇸Memphis, Tennessee, United States
Janus Center for Psychiatric Research
🇺🇸West Palm Beach, Florida, United States
Capstone Clinical Research
🇺🇸Libertyville, Illinois, United States
Kentucky Pediatric/Adult Research
🇺🇸Bardstown, Kentucky, United States
Pedia Research
🇺🇸Owensboro, Kentucky, United States
University of Rochester, School of Medicine and Dentistry
🇺🇸Rochester, New York, United States
Four Rivers Clinical Research, Inc.
🇺🇸Paducah, Kentucky, United States
Psychiatric Associates
🇺🇸Overland Park, Kansas, United States
Piedmont Neuropsychiatry
🇺🇸Charlotte, North Carolina, United States
University Commons Office Park
🇺🇸Durham, North Carolina, United States
BHI, Inc.
🇺🇸Moore, Oklahoma, United States
Oregon Center for Clinical Investigations, Inc
🇺🇸Eugene, Oregon, United States
Oregon Center for Clinical Investigations, Inc.
🇺🇸Salem, Oregon, United States
The Jackson Clinic
🇺🇸Jackson, Tennessee, United States
Claghorn-Lesem Research Clinic Inc.
🇺🇸Bellaire, Texas, United States
Red Oak Psychiatry Associates P.A.
🇺🇸Houston, Texas, United States
R/D Clinical Research, Inc.
🇺🇸Lake Jackson, Texas, United States
NeuroScience, Inc
🇺🇸Herndon, Virginia, United States
ADHD Clinic of San Antonio
🇺🇸San Antonio, Texas, United States
Dominion Clinical Research
🇺🇸Midlothian, Virginia, United States
Eastside Therapeutic Resource
🇺🇸Kirkland, Washington, United States
Oregon Center For Clinical Investigations, Inc.
🇺🇸Portland, Oregon, United States
Summit Research Network
🇺🇸Portland, Oregon, United States
FutureSearch Trials
🇺🇸Austin, Texas, United States
International Clinical Research Associates, LLC
🇺🇸Richmond, Virginia, United States