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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)

Information source: Shire
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention-Deficit Hyperactivity Disorder

Intervention: Lisdexamfetamine Dimesylate (LDX) (Drug); Immediate Release Mixed Amphetamine Salts (MAS-IR) (Drug); LDX Placebo + MAS-IR Placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Shire

Official(s) and/or principal investigator(s):
Gerald Tremblay, Study Director, Affiliation: Shire


To evaluate the sensitivity and responsiveness of a standardized, validated, computer-based, battery of neuro-psychometric tests in adults with ADHD.

Clinical Details

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)

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Primary outcome: Power of Attention Score

Secondary outcome:

Conners Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) Subscale Total Score (T-Score): Inattention/Memory Problems

CAARS-S:S Subscale T-Score: Hyperactivity/Restlessness

CAARS-S:S Subscale T-Score: Impulsivity/Emotional Liability

CAARS-S:S Subscale T-Score: Problems With Self-Concept

CAARS-S:S Subscale T-Score: Attention Deficit Hyperactivity Disorder (ADHD) Index


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


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.

Locations and Contacts

Claghorn-Lesem Research Clinic, Houston, Texas, United States
Additional Information

FDA recall information

FDA-approved label

Starting date: January 2010
Last updated: February 6, 2014

Page last updated: August 23, 2015

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