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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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Lisdexamfetamine Dimesylate (LDX)

Immediate Release Mixed Amphetamine Salts (MAS-IR)

LDX Placebo + MAS-IR Placebo

About this trial

This is an interventional other trial for Attention-Deficit Hyperactivity Disorder focused on measuring ADHD

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Claghorn-Lesem Research Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

LDX + MAS-IR Placebo

MAS-IR + LDX Placebo

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

CAARS-S:S Subscale T-Score: Attention Deficit Hyperactivity Disorder (ADHD) Index

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.

Full Information

NCT ID

NCT01010750

First Posted

November 9, 2009

Last Updated

June 8, 2021

Sponsor

Shire

1. Study Identification

Unique Protocol Identification Number

NCT01010750

Brief Title

Lisdexamfetamine Dimesylate (LDX) Pilot Cognition Study to Evaluate the Utility of a Standardized Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

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 Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

January 5, 2010 (Actual)

Primary Completion Date

March 28, 2010 (Actual)

Study Completion Date

March 28, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shire

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention-Deficit Hyperactivity Disorder

Keywords

ADHD

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LDX + MAS-IR Placebo

Arm Type

Active Comparator

Arm Description

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

Arm Title

MAS-IR + LDX Placebo

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Lisdexamfetamine Dimesylate (LDX)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Immediate Release Mixed Amphetamine Salts (MAS-IR)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

LDX Placebo + MAS-IR Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Power of Attention Score

Description

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 Outcome Measure Information:

Title

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

Description

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

Title

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

Description

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

Title

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

Description

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

Title

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

Description

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

Title

CAARS-S:S Subscale T-Score: Attention Deficit Hyperactivity Disorder (ADHD) Index

Description

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.

Time Frame

2 and 14 hours post-dose on Day 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

No

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Director

Organizational Affiliation

Takeda

Official's Role

Study Director

Facility Information:

Facility Name

Claghorn-Lesem Research Clinic

City

Houston

State/Province

Texas

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24297663

Citation

Martin PT, Corcoran M, Zhang P, Katic A. Randomized, double-blind, placebo-controlled, crossover study of the effects of lisdexamfetamine dimesylate and mixed amphetamine salts on cognition throughout the day in adults with attention-deficit/hyperactivity disorder. Clin Drug Investig. 2014 Feb;34(2):147-57. doi: 10.1007/s40261-013-0156-z.

Results Reference

result

Links:

URL

http://www.fda.gov/opacom/7alerts.html

Description

FDA recall information

URL

http://www.vyvanse.com/pdf/prescribing_information.pdf

Description

FDA-approved label

Attention-Deficit Hyperactivity Disorder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial