- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01010750
Lisdexamfetamine Dimesylate (LDX) Pilot Cognition Study to Evaluate the Utility of a Standardized Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
June 8, 2021 updated by: Shire
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 Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Houston, Texas, United States
- Claghorn-Lesem Research Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: LDX + MAS-IR Placebo
Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo
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Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo
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Active Comparator: MAS-IR + LDX Placebo
Immediate Release Mixed Amphetamine Salts (MAS-IR) + Lisdexamfetamine Dimesylate (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
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Lisdexamfetamine Dimesylate (LDX) Placebo + Immediate Release Mixed Amphetamine Salts (MAS-IR) Placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
pre-dose and at 1, 2, 3, 4, 5, 8, 12, 14 and 16 hours post-dose on Day 7
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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2 and 14 hours post-dose on Day 7
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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.
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2 and 14 hours post-dose on Day 7
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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.
|
2 and 14 hours post-dose on Day 7
|
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.
|
2 and 14 hours post-dose on Day 7
|
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.
|
2 and 14 hours post-dose on Day 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 5, 2010
Primary Completion (Actual)
March 28, 2010
Study Completion (Actual)
March 28, 2010
Study Registration Dates
First Submitted
November 9, 2009
First Submitted That Met QC Criteria
November 9, 2009
First Posted (Estimate)
November 10, 2009
Study Record Updates
Last Update Posted (Actual)
June 14, 2021
Last Update Submitted That Met QC Criteria
June 8, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Neurologic Manifestations
- Dyskinesias
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Attention Deficit Disorder with Hyperactivity
- Hyperkinesis
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Sympathomimetics
- Adrenergic Uptake Inhibitors
- Lisdexamfetamine Dimesylate
- Amphetamine
Other Study ID Numbers
- SPD489-115
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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