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Lisdexamfetamine Dimesylate (LDX) Pilot Cognition Study to Evaluate the Utility of a Standardized Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
Information provided by:
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT01010750
First received: November 9, 2009
Last updated: February 24, 2011
Last verified: February 2011
History of Changes

November 9, 2009
February 24, 2011
January 2010
February 2010   (final data collection date for primary outcome measure)
Power of Attention Score [ Time Frame: pre-dose and at 1, 2, 3, 4, 5, 8, 12, 14 and 16 hours post-dose on Day 7 ] [ Designated as safety issue: No ]
The Power of Attention score reflects the ability to focus attention, and is calculated as the sum of the reaction time, measured in milliseconds, from 3 attention tests (Simple Reaction Time, Choice Reaction Time, and Digit Vigilance Speed). Faster performance (lower times) reflects more intense concentration. A decrease in the Power of Attention score indicates improvement.
The primary pharmacodynamic variable is defined as the absolute Power of Attention score. [ Time Frame: day 7, day 14, day 21 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01010750 on ClinicalTrials.gov Archive Site
  • Conners Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) Subscale Total Score (T-Score): Inattention/Memory Problems [ Time Frame: 2 and 14 hours post-dose on Day 7 ] [ Designated as safety issue: No ]
    Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.
  • CAARS-S:S Subscale T-Score: Hyperactivity/Restlessness [ Time Frame: 2 and 14 hours post-dose on Day 7 ] [ Designated as safety issue: No ]
    Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.
  • CAARS-S:S Subscale T-Score: Impulsivity/Emotional Liability [ Time Frame: 2 and 14 hours post-dose on Day 7 ] [ Designated as safety issue: No ]
    Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.
  • CAARS-S:S Subscale T-Score: Problems With Self-Concept [ Time Frame: 2 and 14 hours post-dose on Day 7 ] [ Designated as safety issue: No ]
    Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.
  • CAARS-S:S Subscale T-Score: Attention Deficit Hyperactivity Disorder (ADHD) Index [ Time Frame: 2 and 14 hours post-dose on Day 7 ] [ Designated as safety issue: No ]
    Consists of 12 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50.
  • The CAARS-S:S score and its subscales. [ Time Frame: day 7, day 14, day 21 ] [ Designated as safety issue: No ]
  • Safety will be assessed by a collection of AE's, vital signs, electrocardiograms, physical examinations, and clinical laboratory tests. [ Time Frame: day 7, day 14, day 21 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Lisdexamfetamine Dimesylate (LDX) Pilot Cognition Study to Evaluate the Utility of a Standardized Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
A Phase I, Randomized, Double Blind, Three-Period Crossover, Estimation Study Using Lisdexamfetamine Dimesylate, Immediate Release Mixed Amphetamine Salts and Placebo to Evaluate the Utility of a Standardized Computer Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

To evaluate the sensitivity and responsiveness of a standardized, validated, computer-based, battery of neuro-psychometric tests in adults with ADHD.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Attention-Deficit Hyperactivity Disorder
  • Drug: Lisdexamfetamine Dimesylate (LDX)
    Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo
  • Drug: Immediate Release Mixed Amphetamine Salts (MAS-IR)
    Immediate Release Mixed Amphetamine Salts (MAS-IR) + Lisdexamfetamine Dimesylate (LDX) placebo
  • Drug: LDX Placebo + MAS-IR Placebo
    Lisdexamfetamine Dimesylate (LDX) Placebo + Immediate Release Mixed Amphetamine Salts (MAS-IR) Placebo
  • Active Comparator: LDX + MAS-IR Placebo
    Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo
    Intervention: Drug: Lisdexamfetamine Dimesylate (LDX)
  • Active Comparator: MAS-IR + LDX Placebo
    Immediate Release Mixed Amphetamine Salts (MAS-IR) + Lisdexamfetamine Dimesylate (LDX) placebo
    Intervention: Drug: Immediate Release Mixed Amphetamine Salts (MAS-IR)
  • Placebo Comparator: Placebo
    Lisdexamfetamine Dimesylate (LDX) Placebo + Immediate Release Mixed Amphetamine Salts (MAS-IR) Placebo
    Intervention: Drug: LDX Placebo + MAS-IR Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
April 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subject meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition; Text Revision (DSM IV TR) criteria for a primary diagnosis of ADHD (diagnostic code 314.00 and 314.01) established by a comprehensive psychiatric evaluation that reviews DSM-IV-TR criteria with at least 6 of the 9 subtype criteria met.
  2. Subject has been previously treated for ADHD with an adequate course of amphetamine therapy with no history of intolerance, or lack of efficacy, as determined by the Investigator.
  3. Subject does not have any physical disability (eg. colorblindness, limitations with use of one or both hands, etc) that would interfere with the subject's participation in or performance on any of the neuropsychometric tests. For a number of these tasks speed is a key factor thus subjects cannot have any obvious impediments/impairments in the use of their hands.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01010750
SPD489-115
Not Provided
Gerald Tremblay, M.D., Shire Pharmaceutical Development Inc.
Shire Development LLC
Not Provided
Study Director: Gerald Tremblay Shire Development LLC
Shire Development LLC
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP