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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)

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ClinicalTrials.gov Identifier: NCT01010750
Recruitment Status : Completed
First Posted : November 10, 2009
Results First Posted : February 25, 2011
Last Update Posted : March 10, 2014
Sponsor:
Information provided by (Responsible Party):
Shire

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

Condition or disease Intervention/treatment Phase
Attention-Deficit Hyperactivity Disorder Drug: Lisdexamfetamine Dimesylate (LDX) Drug: Immediate Release Mixed Amphetamine Salts (MAS-IR) Drug: LDX Placebo + MAS-IR Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
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 Start Date : January 2010
Primary Completion Date : February 2010
Study Completion Date : April 2010


Arm Intervention/treatment
Active Comparator: LDX + MAS-IR Placebo
Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo
Drug: Lisdexamfetamine Dimesylate (LDX)
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
Drug: Immediate Release Mixed Amphetamine Salts (MAS-IR)
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
Drug: LDX Placebo + MAS-IR Placebo
Lisdexamfetamine Dimesylate (LDX) Placebo + Immediate Release Mixed Amphetamine Salts (MAS-IR) Placebo



Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. CAARS-S:S Subscale T-Score: Hyperactivity/Restlessness [ Time Frame: 2 and 14 hours post-dose on Day 7 ]
    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.

  3. CAARS-S:S Subscale T-Score: Impulsivity/Emotional Liability [ Time Frame: 2 and 14 hours post-dose on Day 7 ]
    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.

  4. CAARS-S:S Subscale T-Score: Problems With Self-Concept [ Time Frame: 2 and 14 hours post-dose on Day 7 ]
    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.

  5. CAARS-S:S Subscale T-Score: Attention Deficit Hyperactivity Disorder (ADHD) Index [ Time Frame: 2 and 14 hours post-dose on Day 7 ]
    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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010750


Locations
United States, Texas
Claghorn-Lesem Research Clinic
Houston, Texas, United States
Sponsors and Collaborators
Shire
Investigators
Study Director: Gerald Tremblay Shire

Additional Information:
Publications:
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01010750     History of Changes
Other Study ID Numbers: SPD489-115
First Posted: November 10, 2009    Key Record Dates
Results First Posted: February 25, 2011
Last Update Posted: March 10, 2014
Last Verified: February 2014

Keywords provided by Shire:
ADHD

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Amphetamine
Lisdexamfetamine Dimesylate
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors