A Phase 4 interventional study of lisdexamfetamine dimesylate and Placebo in Attention-deficit/Hyperactivity Disorder, sponsored by University of Rhode Island. Completed at 2 sites in United States. Open to participants aged 18 Years to 28 Years. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by University of Rhode Island · Phase 4, Interventional, and Treatment
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).
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).
1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.
This study's enrollment of 50 is below the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →University of Rhode Island is the lead sponsor of 34 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All participants will be assessed across five conditions (baseline, placebo, 30-mg, 50-mg, \& 70-mg) in a double-blind, crossover design
Drug: lisdexamfetamine dimesylate · Drug: Placebo
30-mg, 50-mg, 70-mg administered for one week in context of double-blind, placebo-controlled crossover design
Also known as: Vyvanse, LDX
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).
Time frame: 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.
Time frame: after receiving Placebo or LDX for 1 week
Participants were recruited from student disabilities and health service offices at two univer- sities in the Northeastern United States (one public and one private).
| Milestone | Healthy Controls | Attention-deficit/Hyperactivity Disorder (ADHD) Participants |
|---|---|---|
| Started | 26 | 24 |
| Completed | 26 | 22 |
| Not completed | 0 | 2 |
| Withdrew: Experienced side effects | 0 | 2 |
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).
| T score | Placebo | LDX 30-mg | LDX 50-mg | LDX 70-mg |
|---|---|---|---|---|
| Conners Adult ADHD Rating Scale - Short Version (CAARS) | 50.59 ± 10.975 | 46.86 ± 9.939 | 47.32 ± 10.092 | 45.36 ± 10.790 |
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.
| T score | Placebo | LDX 30-mg | LDX 50-mg | LDX 70-mg |
|---|---|---|---|---|
| Behavior Rating Inventory of Executive Function - Adult (BRIEF-A) | 65.91 ± 13.023 | 59.23 ± 14.088 | 57.64 ± 14.012 | 54.91 ± 13.219 |
Collected over Adverse event data was collected and updated on a daily basis during the 1 week receiving placebo or LDX.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/24 (0%) | 0/24 (0%) |
| LDX 30-mg | — | 0/24 (0%) | 2/24 (8.3%) |
| LDX 50-mg | — | 0/24 (0%) | 0/24 (0%) |
| LDX 70-mg | — | 0/24 (0%) | 0/24 (0%) |
| Event | Placebo | LDX 30-mg | LDX 50-mg | LDX 70-mg |
|---|---|---|---|---|
| Possible Heart PalpitationsCardiac disorders | 0/24 | 2/24 | 0/24 | 0/24 |
| Age, Categorical(Participants) | ADHD Participants | Healthy Controls | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 24 | 26 | 50 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | ADHD Participants | Healthy Controls | Total |
|---|---|---|---|
| Mean | 20.17 ± 1.2 | 20 ± 1.1 | 20.17 ± 1.2 |
| Sex: Female, Male(Participants) | ADHD Participants | Healthy Controls | Total |
|---|---|---|---|
| Female | 9 | 12 | 21 |
| Male | 15 | 14 | 29 |
| Race/Ethnicity, Customized(participants) | ADHD Participants | Healthy Controls | Total |
|---|---|---|---|
| White non-Hispanic | 22 | 21 | 43 |
| African American | 1 | 0 | 1 |
| Hispanic | 0 | 3 | 3 |
| Asian/Pacific Islander | 1 | 1 | 2 |
| Indian | 0 | 1 | 1 |
| Region of Enrollment(participants) | ADHD Participants | Healthy Controls | Total |
|---|---|---|---|
| United States | 24 | 26 | 50 |
| Conners Adult Rating Scale(T score) | ADHD Participants | Healthy Controls | Total |
|---|---|---|---|
| Mean | 58.04 ± 7.51 | 36.12 ± 4.98 | 47.08 ± NA |
| BRIEF(T score) | ADHD Participants | Healthy Controls | Total |
|---|---|---|---|
| Mean | 65.41 ± 11.661 | 44.31 ± 7.62 | 54.86 ± NA |
| Year in College(participants) | ADHD Participants | Healthy Controls | Total |
|---|---|---|---|
| Freshman | 3 | 5 | 8 |
| Sophomore | 7 | 6 | 13 |
| Junior | 4 | 7 | 11 |
| Senior | 10 | 8 | 18 |
2 further baseline measures are reported on the registry.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Attention Deficit Disorder with Hyperactivity→
University of Rhode Island