Official Title: “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.

Study Type: Interventional

Study Design: Other, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Pharmacodynamics Study

Study Primary Completion Date: February 2010

Intervention(s) in this Clinical Trial

• Drug: Lisdexamfetamine Dimesylate
  • Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo
• Drug: Immediate Release Mixed Amphetamine Salts
  • 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: LDX + MAS-IR Placebo
  • Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo
• Active Comparator: MAS-IR + LDX Placebo
  • Immediate Release Mixed Amphetamine Salts (MAS-IR) + Lisdexamfetamine Dimesylate (LDX) placebo
• Placebo Comparator: Placebo
  • Lisdexamfetamine Dimesylate (LDX) Placebo + Immediate Release Mixed Amphetamine Salts (MAS-IR) Placebo

Primary Measures

• The primary pharmacodynamic variable is defined as the absolute Power of Attention score.
  • Time Frame: day 7, day 14, day 21
    Safety Issue?: No

Secondary Measures

• The CAARS-S:S score and its subscales.
  • Time Frame: day 7, day 14, day 21
    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
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Shire Pharmaceutical Development

Overall Clinical Trial Officials and Contacts

Tim Whitaker Study Director Shire Pharmaceutical Development  

Overall Contact: Shire Call Center 1.866.842.5335 

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01010750

Study ID Number: SPD489-115

ClinicalTrials.gov Identifier: NCT01010750

Health Authority: United States: Food and Drug Administration