Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17
|ClinicalTrials.gov Identifier: NCT00763971|
Recruitment Status : Completed
First Posted : October 1, 2008
Results First Posted : March 22, 2012
Last Update Posted : June 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|ADHD||Drug: Lisdexamfetamine Dimesylate (LDX) Drug: Methylphenidate Hydrochloride Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||336 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase III, Randomised, Double-Blind, Multicentre, Parallel-Group, Placebo- and Active-Controlled, Dose-Optimisation Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)|
|Study Start Date :||October 2008|
|Primary Completion Date :||April 2011|
|Study Completion Date :||April 2011|
Experimental: Lisdexamfetamine Dimesylate (LDX)
Overencapsulated LDX 30, 50, or 70mg
Drug: Lisdexamfetamine Dimesylate (LDX)
30, 50 or 70mg capsule once per day (Overencapsulated)
Other Name: Vyvanse™
Active Comparator: Methylphenidate Hydrochloride
Overencapsulated Concerta 18, 36, or 54mg
Drug: Methylphenidate Hydrochloride
18, 36, or 54mg tablet one per day (Overencapsulated)
Other Name: Concerta®, OROS MPH
Placebo Comparator: Placebo
Placebo capsule once per day (Overencapsulated)
- Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks [ Time Frame: Baseline and up to 7 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. A decrease in score indicates an improvement in ADHD symptomology.
- Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores [ Time Frame: Up to 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 (very much improved) or 2 (much improved) on the scale.
- Change From Baseline in Conner's Parent Rating Scale - Revised (CPRS-R) Total Score at up to 7 Weeks [ Time Frame: Baseline and up to 7 weeks ]The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.
- Health Utilities Index-2 (HUI-2) Scores at up to 7 Weeks [ Time Frame: Baseline and up to 7 weeks ]HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.
- Change From Baseline in the Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at up to 7 Weeks [ Time Frame: Baseline and up to 7 weeks ]The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health.
- Change From Baseline in Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at up to 7 Weeks [ Time Frame: Baseline and up to 7 weeks ]The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
- Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at up to 7 Weeks [ Time Frame: Baseline and up to 7 weeks ]The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.
- Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to 7 weeks ]C-SSRS is a 19-item semi-structured interview designed to capture suicide-related thoughts and behaviors.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763971
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