Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

Phase 3

Completed

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Interventions: Drug: LDX 30 mg
Drug: LDX 50 mg
Drug: Placebo
Drug: LDX 70 mg

Registration Number: NCT00735371

Lead Sponsor: Shire

Brief Summary: The study will evaluate the efficacy of LDX treatment group compared to placebo on the change from Baseline ADHD-RS-IV score at endpoint.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 314

Inclusion Criteria

Meet DSM-IV-TR criteria for a primary diagnosis of ADHD
Baseline ADHD-RS-IV score >=28
BP w/in 95th percentile for age, gender, and height

Exclusion Criteria

Subject has controlled or uncontrolled comorbid psychiatric diagnosis
Subject has conduct disorder
Suicidal
Under or overweight
Concurrent chronic or acute illness that might confound results.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lisdexamfetamine Dimesylate (LDX) 30 mg	LDX 30 mg	-
LDX 50 mg	LDX 50 mg	-
Placebo	Placebo	-
LDX 70 mg	LDX 70 mg	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 Weeks	Baseline and 1, 2, 3 and 4 weeks	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
Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	1, 2, 3 and 4 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 (very much improved) or 2 (much improved) on the scale.
Youth Quality of Life-Research Version (YQOL-R) Total Score	Baseline and 4 weeks	The Youth Quality of Life-research version (YQOL-R) is a validated 56-item generic instrument for comparing quality of life of adolescents across condition groups that scores each question on a scale from 0 (never) to 4 (very often). The YQOL scores are transformed to a 0-100 scale for easy interpretability. Higher scores indicate better quality of life.

Trial Locations

Locations (44): Florida Clinical Research Center, LLC
🇺🇸
Bradenton, Florida, United States
Amedica Research Institute, Inc.
🇺🇸
Hialeah, Florida, United States
Northwest Behavioral Research Center
🇺🇸
Marietta, Georgia, United States
Psychiatric Associates
🇺🇸
Overland Park, Kansas, United States
Pedia Research, LLC
🇺🇸
Owensboro, Kentucky, United States
Clinical Study Centers, LLC
🇺🇸
Little Rock, Arkansas, United States
Miami Research Associates
🇺🇸
South Miami, Florida, United States
Janus Center for Psychiatric Research
🇺🇸
West Palm Beach, Florida, United States
Valerie Arnold
🇺🇸
Memphis, Tennessee, United States
Neuropsychiatric Associates
🇺🇸
Woodstock, Vermont, United States
Center for Psychiatry and Behavioral Medicine, Inc
🇺🇸
Las Vegas, Nevada, United States
University Hospitals of Cleveland Division of Child Adolescent Psychiatry
🇺🇸
Cleveland, Ohio, United States
Youth and Family Research Program/WP IC ADHD Research Program
🇺🇸
Pittsburgh, Pennsylvania, United States
Bayou City Research, Ltd
🇺🇸
Houston, Texas, United States
Children's Specialized Hospital
🇺🇸
Toms River, New Jersey, United States
Cientifica, Inc at Prairie View
🇺🇸
Newton, Kansas, United States
Innovis Health/Odyssey Research
🇺🇸
Fargo, North Dakota, United States
Vince and Associates Clinical Research, Inc.
🇺🇸
Overland Park, Kansas, United States
OCCI Inc
🇺🇸
Salem, Oregon, United States
Red Oak Psychiatry Associates, PA
🇺🇸
Houston, Texas, United States
IPS Research Company
🇺🇸
Oklahoma City, Oklahoma, United States
Summit Research Network
🇺🇸
Portland, Oregon, United States
ADHD Clinic of San Antonio
🇺🇸
San Antonio, Texas, United States
Sarkis Clinical Trials
🇺🇸
Gainesville, Florida, United States
FutureSearch Trials
🇺🇸
Austin, Texas, United States
Psychiatric Centers at San Diego (PCSD-Feighner Research Institute)
🇺🇸
San Diego, California, United States
Peninsula Research Associates, Inc
🇺🇸
Rolling Hills Estates, California, United States
Valley Clinical Research, Inc.
🇺🇸
El Centro, California, United States
Elite Clinical Trials, Inc
🇺🇸
Wildomar, California, United States
Atlanta Center for Medical Research
🇺🇸
Atlanta, Georgia, United States
Capstone Clinical Research
🇺🇸
Libertyville, Illinois, United States
Clinco Inc.
🇺🇸
Terre Haute, Indiana, United States
Bart Sangal, MD
🇺🇸
Troy, Michigan, United States
Four Rivers Clinical Research, Inc.
🇺🇸
Paducah, Kentucky, United States
Bioscience Research, LLC
🇺🇸
Mount Kisco, New York, United States
Triangle Neuropsychiatry, PLLC
🇺🇸
Durham, North Carolina, United States
OCCI
🇺🇸
Eugene, Oregon, United States
CRI Worldwide
🇺🇸
Philadelphia, Pennsylvania, United States
Vermont Clinical Study Center
🇺🇸
Burlington, Vermont, United States
Dominion Clinical Research
🇺🇸
Midlothian, Virginia, United States
Northwest Clinical Research Center
🇺🇸
Bellevue, Washington, United States
Neuroscience, Inc
🇺🇸
Herndon, Virginia, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸
Orlando, Florida, United States
Louisiana Research Associates, Inc
🇺🇸
New Orleans, Louisiana, United States