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

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01010750

Enrollment

Registered

2009-11-10

Start date

2010-01-05

Completion date

2010-03-28

Last updated

2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention-Deficit Hyperactivity Disorder

Keywords

ADHD

Brief summary

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

Interventions

DRUGLisdexamfetamine Dimesylate (LDX)

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

DRUGImmediate Release Mixed Amphetamine Salts (MAS-IR)

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

DRUGLDX Placebo + MAS-IR Placebo

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Power of Attention Score	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

Measure	Time frame	Description
Conners Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) Subscale Total Score (T-Score): Inattention/Memory Problems	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.
CAARS-S:S Subscale T-Score: Hyperactivity/Restlessness	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.
CAARS-S:S Subscale T-Score: Impulsivity/Emotional Liability	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.
CAARS-S:S Subscale T-Score: Problems With Self-Concept	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.
CAARS-S:S Subscale T-Score: Attention Deficit Hyperactivity Disorder (ADHD) Index	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.

Countries

United States

Participant flow

Pre-assignment details

Each of the 3 treatment regimens was administered daily for 7 days (a total of 21 days of treatment). There was no washout between regimens.

Participants by arm

Arm	Count
LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo	3
LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg	4
Placebo First, Them LDX 50 mg, Then MAS-IR 20 mg	3
Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg	3
MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo	2
MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg	3
Total	18

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005
Second Intervention	Adverse Event	0	1	0	0	0	0

Baseline characteristics

Characteristic	Total	MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg	LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo	LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg	MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo	Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg	Placebo First, Them LDX 50 mg, Then MAS-IR 20 mg
Age, Continuous	30.8 years STANDARD_DEVIATION 10.75	30.0 years STANDARD_DEVIATION 11.36	25.0 years STANDARD_DEVIATION 1	24.8 years STANDARD_DEVIATION 6.7	53.0 years STANDARD_DEVIATION 0	31.3 years STANDARD_DEVIATION 11.37	30.3 years STANDARD_DEVIATION 6.11
Age, Customized <18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Customized >=56 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Customized Between 18 and 55 years	18 Participants	3 Participants	3 Participants	4 Participants	2 Participants	3 Participants	3 Participants
Region of Enrollment United States	18 Participants	3 Participants	3 Participants	4 Participants	2 Participants	3 Participants	3 Participants
Sex: Female, Male Female	7 Participants	2 Participants	0 Participants	2 Participants	1 Participants	1 Participants	1 Participants
Sex: Female, Male Male	11 Participants	1 Participants	3 Participants	2 Participants	1 Participants	2 Participants	2 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	12 / 18	9 / 17	8 / 17
serious Total, serious adverse events	0 / 18	0 / 17	0 / 17

Outcome results

Primary

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

Population: The Pharmacodynamic Set (PD) is all subjects in the Safety Set who had at least 1 post-dose assessment of the pharmacodynamic variables. The Safety Set contains all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Arm	Measure	Group	Value (MEAN)	Dispersion
LDX 50 mg	Power of Attention Score	half an hour prior to dosing	1260.7 milliseconds	Standard Error 34
LDX 50 mg	Power of Attention Score	1 hour post-dose	1244.6 milliseconds	Standard Error 32.887
LDX 50 mg	Power of Attention Score	2 hours post-dose	1315.5 milliseconds	Standard Error 67.246
LDX 50 mg	Power of Attention Score	3 hours post-dose	1219.1 milliseconds	Standard Error 33.428
LDX 50 mg	Power of Attention Score	4 hours post-dose	1225.9 milliseconds	Standard Error 40.192
LDX 50 mg	Power of Attention Score	5 hours post-dose	1179.6 milliseconds	Standard Error 35.022
LDX 50 mg	Power of Attention Score	8 hours post-dose	1212.0 milliseconds	Standard Error 36.113
LDX 50 mg	Power of Attention Score	12 hours post-dose	1232.4 milliseconds	Standard Error 48.183
LDX 50 mg	Power of Attention Score	14 hours post-dose	1199.3 milliseconds	Standard Error 35.947
LDX 50 mg	Power of Attention Score	16 hours post-dose	1202.6 milliseconds	Standard Error 37.135
MAS-IR 20 mg	Power of Attention Score	14 hours post-dose	1270.1 milliseconds	Standard Error 39.539
MAS-IR 20 mg	Power of Attention Score	half an hour prior to dosing	1324.1 milliseconds	Standard Error 47.142
MAS-IR 20 mg	Power of Attention Score	5 hours post-dose	1251.4 milliseconds	Standard Error 42.607
MAS-IR 20 mg	Power of Attention Score	4 hours post-dose	1236.5 milliseconds	Standard Error 36.839
MAS-IR 20 mg	Power of Attention Score	1 hour post-dose	1307.4 milliseconds	Standard Error 42.908
MAS-IR 20 mg	Power of Attention Score	16 hours post-dose	1255.9 milliseconds	Standard Error 36.378
MAS-IR 20 mg	Power of Attention Score	12 hours post-dose	1239.3 milliseconds	Standard Error 38.465
MAS-IR 20 mg	Power of Attention Score	2 hours post-dose	1255.0 milliseconds	Standard Error 33.905
MAS-IR 20 mg	Power of Attention Score	8 hours post-dose	1259.3 milliseconds	Standard Error 35.883
MAS-IR 20 mg	Power of Attention Score	3 hours post-dose	1229.6 milliseconds	Standard Error 37.865
Placebo	Power of Attention Score	12 hours post-dose	1262.1 milliseconds	Standard Error 40.795
Placebo	Power of Attention Score	3 hours post-dose	1301.0 milliseconds	Standard Error 40.864
Placebo	Power of Attention Score	4 hours post-dose	1275.4 milliseconds	Standard Error 35.302
Placebo	Power of Attention Score	5 hours post-dose	1330.3 milliseconds	Standard Error 49.623
Placebo	Power of Attention Score	14 hours post-dose	1270.5 milliseconds	Standard Error 44.814
Placebo	Power of Attention Score	8 hours post-dose	1304.5 milliseconds	Standard Error 43.802
Placebo	Power of Attention Score	half an hour prior to dosing	1272.8 milliseconds	Standard Error 33.729
Placebo	Power of Attention Score	16 hours post-dose	1270.3 milliseconds	Standard Error 48.581
Placebo	Power of Attention Score	1 hour post-dose	1253.1 milliseconds	Standard Error 24.174
Placebo	Power of Attention Score	2 hours post-dose	1296.2 milliseconds	Standard Error 39.808

Secondary

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.