Attention-deficit/Hyperactivity DisorderPhase 4NCT01342445
Effects of LDX on Functioning of College Students With ADHD
A Phase 4 study testing lisdexamfetamine dimesylate in people with Attention-deficit/Hyperactivity Disorder, run by University of Rhode Island at 2 sites in United States.
Trial summary
The purpose of this study was to evaluate the effects of lisdexamfetamine dimesylate, a prodrug stimulant, on the behavioral, academic, and psychosocial functioning of college students with attention-deficit/hyperactivity disorder (ADHD). Read more about this study
- Who is it for?
- Ages 18 to 28 years
- Conditions the study is for
- Attention-deficit/Hyperactivity Disorder
- What is being tested?
- lisdexamfetamine dimesylate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to Dec 2010
- Phase
- Phase 4
- 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 28 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnostic Statistical Manual of Mental Disorders 4th edition-text revision (DSM-IV-TR) criteria for ADHD based on self- and parent-report using questionnaires and clinical interview
Who cannot join
- significant cardiac condition based on medical history and/or physical examination
- significant substance abuse based on self-report and toxicology screen at intake
- significant symptoms of major depressive disorder, bipolar disorder, or thought disorder based on initial diagnostic interview
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Department of Education and Human Services, Lehigh University
Bethlehem, Pennsylvania, 18015
Department of Psychology, University of Rhode Island
Kingston, Rhode Island, 02881
About this study
Official title: Effects of Vyvanse on the Behavioral, Academic, and Psychosocial Functioning of College Students With ADHD
The purpose of this study was to evaluate the effects of lisdexamfetamine dimesylate, a prodrug stimulant, on the behavioral, academic, and psychosocial functioning of college students with attention-deficit/hyperactivity disorder (ADHD). Twenty-five college students with ADHD from two universities (University of Rhode Island and Lehigh University) completed a within-subject, placebo-controlled research trial. Dependent measures tapping behavioral, psychosocial, and academic functioning were completed on a weekly basis across five conditions (baseline, placebo, and 30-mg, 50-mg, and 70-mg lisdexamfetamine).
Read the detailed description
Objective: Evaluate stimulant medication on symptoms and functioning for college students with ADHD using double-blind, placebo-controlled, crossover design. Method: Participants included 24 college students with ADHD and 26 college students without psychopathology. Lisdexamfetamine dimesylate (LDX) examined for ADHD participants over five weekly phases (no-drug baseline, placebo, 30, 50, \& 70-mg LDX per day). Self-report rating scales of functioning and direct assessment of ADHD symptoms, verbal learning/memory, and adverse side-effects were collected (baseline only for control students).
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Being tested
- lisdexamfetamine dimesylate, Placebo
- 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 dimesylateDrug
Also called Vyvanse, LDX
30-mg, 50-mg, 70-mg administered for one week in context of double-blind, placebo-controlled crossover design
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| lisdexamfetamine dimesylate | Experimental | All participants will be assessed across five conditions (baseline, placebo, 30-mg, 50-mg, \& 70-mg) in a double-blind, crossover design Receives: Drug: lisdexamfetamine dimesylate; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conners Adult ADHD Rating Scale - Short Version (CAARS)
CAARS ADHD Index, adult self-report measure of ADHD symptoms. T-scores (mean = 50; standard deviation = 10) for all subscales on the short version were used as dependent measures with higher scores representing greater ADHD symptomatology (and ultimately a worse outcome in this study).
Measured: after receiving Placebo or LDX for 1 week
Behavior Rating Inventory of Executive Function - Adult (BRIEF-A)
BRIEF-A is a standardized self-report measure that captures adults' views of their own self-regulation in their everyday environment. Metacognition Index T-scores (mean = 50; standard deviation = 10) were used as dependent measures with higher scores representing greater deficit in planning/organizational skills critical for college success.
Measured: after receiving Placebo or LDX for 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startSep 2009
- Primary completionDec 2010
- Study completionDec 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- Lehigh University
- Responsible party
- Principal investigator, Lisa Weyandt, University of Rhode Island
- Investigators
- Lisa L Weyandt, PhD, Principal investigator, University of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342445
- Sponsor's protocol ID
- Shire-80000311112
- Status last verified
- Apr 2025
- First submitted
- 21 Apr 2011
- Last updated
- 24 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dupaul GJ, Weyandt LL, Rossi JS, Vilardo BA, O'Dell SM, Carson KM, Verdi G, Swentosky A. Double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in college students with ADHD. J Atten Disord. 2012 Apr;16(3):202-20. doi: 10.1177/1087054711427299. Epub 2011 Dec 12.
PubMed 22166471
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vyvanse on the Behavioral, Academic, and Psychosocial Functioning of College Students With ADHD
- ClinicalTrials.gov ID
- NCT01342445
- Acronym / sponsor ID
- Shire-80000311112
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Rhode IslandUniversity, hospital or other
- Collaborators
- Lehigh University
- Study start
- Sep 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Apr 2011 (estimated)
- Results
- Posted 8 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the effects of lisdexamfetamine dimesylate, a prodrug stimulant, on the behavioral, academic, and psychosocial functioning of college students with attention-deficit/hyperactivity disorder (ADHD). Twenty-five college students with ADHD from two universities (University of Rhode Island and Lehigh University) completed a within-subject, placebo-controlled research trial. Dependent measures tapping behavioral, psychosocial, and academic functioning were completed on a weekly basis across five conditions (baseline, placebo, and 30-mg, 50-mg, and 70-mg lisdexamfetamine).
Detailed description
Objective: Evaluate stimulant medication on symptoms and functioning for college students with ADHD using double-blind, placebo-controlled, crossover design. Method: Participants included 24 college students with ADHD and 26 college students without psychopathology. Lisdexamfetamine dimesylate (LDX) examined for ADHD participants over five weekly phases (no-drug baseline, placebo, 30, 50, \& 70-mg LDX per day). Self-report rating scales of functioning and direct assessment of ADHD symptoms, verbal learning/memory, and adverse side-effects were collected (baseline only for control students).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lisdexamfetamine dimesylate | Experimental | Drug: lisdexamfetamine dimesylate, Drug: PlaceboAll participants will be assessed across five conditions (baseline, placebo, 30-mg, 50-mg, \& 70-mg) in a double-blind, crossover design |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnostic Statistical Manual of Mental Disorders 4th edition-text revision (DSM-IV-TR) criteria for ADHD based on self- and parent-report using questionnaires and clinical interview
Key exclusion criteria (3 listed)
- significant cardiac condition based on medical history and/or physical examination
- significant substance abuse based on self-report and toxicology screen at intake
- significant symptoms of major depressive disorder, bipolar disorder, or thought disorder based on initial diagnostic interview
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 dimesylateAlso: Vyvanse, LDX30-mg, 50-mg, 70-mg administered for one week in context of double-blind, placebo-controlled crossover design | Drug | lisdexamfetamine dimesylate |
| Placebo | Drug | lisdexamfetamine dimesylate |
Primary outcome
Conners Adult ADHD Rating Scale - Short Version (CAARS)
Time frame: after receiving Placebo or LDX for 1 week
CAARS ADHD Index, adult self-report measure of ADHD symptoms. T-scores (mean = 50; standard deviation = 10) for all subscales on the short version were used as dependent measures with higher scores representing greater ADHD symptomatology (and ultimately a worse outcome in this study).
Behavior Rating Inventory of Executive Function - Adult (BRIEF-A)
Time frame: after receiving Placebo or LDX for 1 week
BRIEF-A is a standardized self-report measure that captures adults' views of their own self-regulation in their everyday environment. Metacognition Index T-scores (mean = 50; standard deviation = 10) were used as dependent measures with higher scores representing greater deficit in planning/organizational skills critical for college success.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22166471Dupaul GJ, Weyandt LL, Rossi JS, Vilardo BA, O'Dell SM, Carson KM, Verdi G, Swentosky A. Double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in college students with ADHD. J Atten Disord. 2012 Apr;16(3):202-20. doi: 10.1177/1087054711427299. Epub 2011 Dec 12.
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
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
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.
Lisa L Weyandt, PhD principal investigator
University of Rhode Island
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lisdexamfetamine dimesylate in people with Attention-deficit/Hyperactivity Disorder, run by University of Rhode Island at 2 sites in United States.
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 1 inclusion and 3 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 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 8 Apr 2014). 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?
Conners Adult ADHD Rating Scale - Short Version (CAARS) (time frame: after receiving Placebo or LDX for 1 week). The study lists 2 primary outcomes in all. 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 NCT01342445, 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 24 Apr 2025.