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) | Crick

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

18

Conditions

Attention-Deficit Hyperactivity Disorder

Interventions

Lisdexamfetamine Dimesylate (LDX)DRUG

Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo

Immediate Release Mixed Amphetamine Salts (MAS-IR)DRUG

Immediate Release Mixed Amphetamine Salts (MAS-IR) + Lisdexamfetamine Dimesylate (LDX) placebo

LDX Placebo + MAS-IR PlaceboDRUG

Lisdexamfetamine Dimesylate (LDX) Placebo + Immediate Release Mixed Amphetamine Salts (MAS-IR) Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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 (1)

Claghorn-Lesem Research Clinic

Houston, Texas, United States

Outcomes

Primary Outcomes

Power of Attention Score

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.

Time frame: pre-dose and at 1, 2, 3, 4, 5, 8, 12, 14 and 16 hours post-dose on Day 7

Secondary Outcomes

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

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.

Time frame: 2 and 14 hours post-dose on Day 7

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

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.

Time frame: 2 and 14 hours post-dose on Day 7

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

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.

Time frame: 2 and 14 hours post-dose on Day 7

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

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.