Phase 1
N=18
Lisdexamfetamine Dimesylate (LDX) Pilot Cognition Study to Evaluate the Utility of a Standardized Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
Attention-Deficit Hyperactivity Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01010750 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Feb 2011
Primary outcome: Primary: Power of Attention Score — 1260.7; 1324.1; 1272.8; 1244.6 milliseconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Lisdexamfetamine Dimesylate (LDX) (Drug); Immediate Release Mixed Amphetamine Salts (MAS-IR) (Drug); LDX Placebo + MAS-IR Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Power of Attention Score |
1260.7; 1324.1; 1272.8; 1244.6; 1307.4; 1253.1 | — |
| SECONDARY Conners Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) Subscale Total Score (T-Score): Inattention/Memory Problems |
66.16; 63.39; 64.92; 65.78; 64.45; 66.33 | — |
| SECONDARY CAARS-S:S Subscale T-Score: Hyperactivity/Restlessness |
64.21; 63.62; 63.28; 65.08; 63.41; 65.74 | — |
| SECONDARY CAARS-S:S Subscale T-Score: Impulsivity/Emotional Liability |
55.46; 54.58; 54.66; 57.82; 51.53; 55.78 | — |
| SECONDARY CAARS-S:S Subscale T-Score: Problems With Self-Concept |
58.71; 59.78; 58.40; 59.68; 59.54; 59.68 | — |
| SECONDARY CAARS-S:S Subscale T-Score: Attention Deficit Hyperactivity Disorder (ADHD) Index |
64.82; 63.90; 64.59; 66.56; 63.09; 64.85 | — |
Summary
To evaluate the sensitivity and responsiveness of a standardized, validated, computer-based, battery of neuro-psychometric tests in adults with ADHD.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01010750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.