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
Summary
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 ProblemsCAARS-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
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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
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