Attention-Deficit Hyperactivity DisorderPhase 1NCT01010750

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 1 study testing Lisdexamfetamine Dimesylate (LDX) and Immediate Release Mixed Amphetamine Salts (MAS-IR) in people with Attention-Deficit Hyperactivity Disorder, run by Shire at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Attention-Deficit Hyperactivity Disorder
What is being tested?: Lisdexamfetamine Dimesylate (LDX) and Immediate Release Mixed Amphetamine Salts (MAS-IR)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 5 Jan 2010to 28 Mar 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Claghorn-Lesem Research Clinic
Houston, Texas

Other trials in United States

About this study

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)

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

Conditions: Attention-Deficit Hyperactivity Disorder
Being tested: Lisdexamfetamine Dimesylate (LDX), Immediate Release Mixed Amphetamine Salts (MAS-IR), LDX Placebo + MAS-IR Placebo
Keywords: ADHD
Medical subject headings: Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01010750
Study group	Role	What they receive
LDX + MAS-IR Placebo	Active comparator	Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo Receives: Drug: Lisdexamfetamine Dimesylate (LDX)
MAS-IR + LDX Placebo	Active comparator	Immediate Release Mixed Amphetamine Salts (MAS-IR) + Lisdexamfetamine Dimesylate (LDX) placebo Receives: Drug: Immediate Release Mixed Amphetamine Salts (MAS-IR)
Placebo	Placebo comparator	Lisdexamfetamine Dimesylate (LDX) Placebo + Immediate Release Mixed Amphetamine Salts (MAS-IR) Placebo Receives: Drug: LDX Placebo + MAS-IR Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 and 14 hours post-dose on Day 7
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.
Measured: 2 and 14 hours post-dose on Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jan 201028 Mar 2010

First posted10 Nov 2009 (estimated)
Study start5 Jan 2010
Primary completion28 Mar 2010
Study completion28 Mar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Attention-Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01010750
Sponsor's protocol ID: SPD489-115
Status last verified: Jun 2021
First submitted: 9 Nov 2009
Last updated: 14 Jun 2021
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 24297663

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Attention-Deficit Hyperactivity Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT01010750
Acronym / sponsor ID: SPD489-115
Conditions: Attention-Deficit Hyperactivity Disorder
Keywords: ADHD
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: ShireIndustry (pharma, biotech, devices)
Study start: 5 Jan 2010 (actual)
Primary completion: 28 Mar 2010 (actual)
Study completion: 28 Mar 2010 (actual)
First posted: 10 Nov 2009 (estimated)
Results: Posted 25 Feb 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
LDX + MAS-IR Placebo	Active comparator	Drug: Lisdexamfetamine Dimesylate (LDX)Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo
MAS-IR + LDX Placebo	Active comparator	Drug: Immediate Release Mixed Amphetamine Salts (MAS-IR)Immediate Release Mixed Amphetamine Salts (MAS-IR) + Lisdexamfetamine Dimesylate (LDX) placebo
Placebo	Placebo comparator	Drug: LDX Placebo + MAS-IR PlaceboLisdexamfetamine Dimesylate (LDX) Placebo + Immediate Release Mixed Amphetamine Salts (MAS-IR) Placebo

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lisdexamfetamine Dimesylate (LDX)Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo	Drug	LDX + MAS-IR Placebo
Immediate Release Mixed Amphetamine Salts (MAS-IR)Immediate Release Mixed Amphetamine Salts (MAS-IR) + Lisdexamfetamine Dimesylate (LDX) placebo	Drug	MAS-IR + LDX Placebo
LDX Placebo + MAS-IR PlaceboLisdexamfetamine Dimesylate (LDX) Placebo + Immediate Release Mixed Amphetamine Salts (MAS-IR) Placebo	Drug	Placebo

Primary outcome

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.

5 secondary outcomes

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
CAARS-S:S Subscale T-Score: Hyperactivity/Restlessness
Time frame: 2 and 14 hours post-dose on Day 7
CAARS-S:S Subscale T-Score: Impulsivity/Emotional Liability
Time frame: 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
CAARS-S:S Subscale T-Score: Attention Deficit Hyperactivity Disorder (ADHD) Index
Time frame: 2 and 14 hours post-dose on Day 7

Results and safety

Results posted to the registry on 25 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo	3	3
LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg	4	4
Placebo First, Then LDX 50 mg, Then MAS-IR 20 mg	3	3
Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg	3	3
MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo	2	2
MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg	3	3

Primary outcome: 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. Mean (Standard Error). Unit: milliseconds

Measure	LDX 50 mg n = 18	MAS-IR 20 mg n = 17	Placebo n = 17
half an hour prior to dosing	1260.7 (34.000)	1324.1 (47.142)	1272.8 (33.729)
1 hour post-dose	1244.6 (32.887)	1307.4 (42.908)	1253.1 (24.174)
2 hours post-dose	1315.5 (67.246)	1255.0 (33.905)	1296.2 (39.808)
3 hours post-dose	1219.1 (33.428)	1229.6 (37.865)	1301.0 (40.864)
4 hours post-dose	1225.9 (40.192)	1236.5 (36.839)	1275.4 (35.302)
5 hours post-dose	1179.6 (35.022)	1251.4 (42.607)	1330.3 (49.623)
8 hours post-dose	1212.0 (36.113)	1259.3 (35.883)	1304.5 (43.802)
12 hours post-dose	1232.4 (48.183)	1239.3 (38.465)	1262.1 (40.795)

Population analysed: 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.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LDX 50 mg	0 of 18 (0%)	12 of 18 (66.7%)	Not reported
MAS-IR 20 mg	0 of 17 (0%)	9 of 17 (52.9%)	Not reported
Placebo	0 of 17 (0%)	8 of 17 (47.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24297663Martin 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.
FDA recall informationLink provided by the sponsor.

Related trials for Attention-Deficit Hyperactivity Disorder

Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
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Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01010750, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.