Clinical trial NCT00735371: Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
Official title: A Phase III, Randomized, Double-Blind, Multi-Center, Parallel-Group, Placebo-Controlled, Forced-dose Titration, Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Adolescents Aged 13-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2008-08-14
Enrollment: 314
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 Weeks
timeFrame: Baseline and 1, 2, 3 and 4 weeks
Secondary outcomes:
measure: Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
timeFrame: 1, 2, 3 and 4 Weeks
measure: Youth Quality of Life-Research Version (YQOL-R) Total Score
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Clinical Study Centers, LLC
state: Arkansas
city: El Centro
country: United States
facility: Valley Clinical Research, Inc.
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates, Inc
state: California
city: San Diego
country: United States
facility: Psychiatric Centers at San Diego (PCSD-Feighner Research Institute)
state: California
city: Wildomar
country: United States
facility: Elite Clinical Trials, Inc
state: California
city: Bradenton
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: Amedica Research Institute, Inc.
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: West Palm Beach
country: United States
facility: Janus Center for Psychiatric Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Marietta
country: United States
facility: Northwest Behavioral Research Center
state: Georgia
city: Libertyville
country: United States
facility: Capstone Clinical Research
state: Illinois
city: Terre Haute
country: United States
facility: Clinco Inc.
state: Indiana
city: Newton
country: United States
facility: Cientifica, Inc at Prairie View
state: Kansas
city: Overland Park
country: United States
facility: Psychiatric Associates
state: Kansas
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research, Inc.
state: Kansas
city: Owensboro
country: United States
facility: Pedia Research, LLC
state: Kentucky
city: Paducah
country: United States
facility: Four Rivers Clinical Research, Inc.
state: Kentucky
city: New Orleans
country: United States
facility: Louisiana Research Associates, Inc
state: Louisiana
city: Troy
country: United States
facility: Bart Sangal, MD
state: Michigan
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine, Inc
state: Nevada
city: Toms River
country: United States
facility: Children's Specialized Hospital
state: New Jersey
city: Mount Kisco
country: United States
facility: Bioscience Research, LLC
state: New York
city: Durham
country: United States
facility: Triangle Neuropsychiatry, PLLC
state: North Carolina
city: Fargo
country: United States
facility: Innovis Health/Odyssey Research
state: North Dakota
city: Cleveland
country: United States
facility: University Hospitals of Cleveland Division of Child Adolescent Psychiatry
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Eugene
country: United States
facility: OCCI
state: Oregon
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Salem
country: United States
facility: OCCI Inc
state: Oregon
city: Philadelphia
country: United States
facility: CRI Worldwide
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Youth and Family Research Program/WP IC ADHD Research Program
state: Pennsylvania
city: Memphis
country: United States
facility: Valerie Arnold
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Houston
country: United States
facility: Bayou City Research, Ltd
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates, PA
state: Texas
city: San Antonio
country: United States
facility: ADHD Clinic of San Antonio
state: Texas
city: Burlington
country: United States
facility: Vermont Clinical Study Center
state: Vermont
city: Woodstock
country: United States
facility: Neuropsychiatric Associates
state: Vermont
city: Herndon
country: United States
facility: Neuroscience, Inc
state: Virginia
city: Midlothian
country: United States
facility: Dominion Clinical Research
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Findling RL, Childress AC, Cutler AJ, Gasior M, Hamdani M, Ferreira-Cornwell MC, Squires L. Efficacy and safety of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2011 Apr;50(4):395-405. doi: 10.1016/j.jaac.2011.01.007. Epub 2011 Mar 3.