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

Study Timeline

• Study First Submitted: 2008-08-12
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-14
• Study Start: 2008-10-08
• Primary Completion: 2009-04-06
• Study Completion: 2009-04-06
• Results First Submitted: 2010-02-01
• Results First Submitted QC: 2010-02-01
• Results First Posted: 2010-02-23
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-08
• Last Update Posted: 2021-06-14

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)

Clinical Study Centers, LLC; 🇺🇸 Little Rock, Arkansas, United States

Valley Clinical Research, Inc.; 🇺🇸 El Centro, California, United States

Peninsula Research Associates, Inc; 🇺🇸 Rolling Hills Estates, California, United States

Psychiatric Centers at San Diego (PCSD-Feighner Research Institute); 🇺🇸 San Diego, California, United States

Elite Clinical Trials, Inc; 🇺🇸 Wildomar, California, United States

Florida Clinical Research Center, LLC; 🇺🇸 Bradenton, Florida, United States

Sarkis Clinical Trials; 🇺🇸 Gainesville, Florida, United States

Amedica Research Institute, Inc.; 🇺🇸 Hialeah, Florida, United States

Clinical Neuroscience Solutions, Inc.; 🇺🇸 Orlando, Florida, United States

Miami Research Associates; 🇺🇸 South Miami, Florida, United States

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