Attention-deficit/Hyperactivity Disorder
Conditions
Brief 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). 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).
Interventions
DRUGlisdexamfetamine dimesylate
30-mg, 50-mg, 70-mg administered for one week in context of double-blind, placebo-controlled crossover design
DRUGPlacebo
Sponsors
Lehigh University
University of Rhode Island
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 28 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conners Adult ADHD Rating Scale - Short Version (CAARS) | 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) | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from student disabilities and health service offices at two univer- sities in the Northeastern United States (one public and one private).
Pre-assignment details
Almost all participants completed all stages of the trial. One participant withdrew from the study after a possible adverse reaction.
Participants by arm
| Arm | Count |
|---|---|
| ADHD Participants All participants completed the Conners' Adult ADHD Rating Scales-Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning-Adult Version (BRIEF) at baseline and were randomly assigned to one of six medication orders using placebo, 30-mg, 50 and 70 mg LDX in the context of a double-blind, crossover design, with repeated measures at the end of each drug phase. Phase orders (following baseline) were assigned in a counterbalanced fashion across participants. To avoid starting any participant with the highest dosage, the 50-mg condition always preceded the 70-mg condition. | 24 |
| Healthy Controls All participants completed the Conners' Adult ADHD Rating Scales-Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning-Adult Version (BRIEF) at baseline only and received no drug. | 26 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Experienced side effects | 0 | 2 |
Baseline characteristics
| Characteristic | ADHD Participants | Healthy Controls | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 26 Participants | 50 Participants |
| Age, Continuous | 20.17 years STANDARD_DEVIATION 1.2 | 20 years STANDARD_DEVIATION 1.1 | 20.17 years STANDARD_DEVIATION 1.2 |
| BRIEF | 65.41 T score STANDARD_DEVIATION 11.661 | 44.31 T score STANDARD_DEVIATION 7.62 | 54.86 T score |
| Conners Adult Rating Scale | 58.04 T score STANDARD_DEVIATION 7.51 | 36.12 T score STANDARD_DEVIATION 4.98 | 47.08 T score |
| Father's level of education Bachelor's degree | 11 participants | 7 participants | 18 participants |
| Father's level of education Graduate degree | 5 participants | 9 participants | 14 participants |
| Father's level of education HS diploma or equivalent | 6 participants | 6 participants | 12 participants |
| Father's level of education Less than high school (HS) | 0 participants | 0 participants | 0 participants |
| Father's level of education Some college | 2 participants | 3 participants | 5 participants |
| Father's level of education Training program or certificate | 0 participants | 1 participants | 1 participants |
| Mother's level of education Bachelor's degree | 9 participants | 8 participants | 17 participants |
| Mother's level of education Graduate degree | 6 participants | 9 participants | 15 participants |
| Mother's level of education HS diploma or equivalent | 3 participants | 3 participants | 6 participants |
| Mother's level of education Less than high school (HS) | 1 participants | 0 participants | 1 participants |
| Mother's level of education Some college | 5 participants | 4 participants | 9 participants |
| Mother's level of education Training program or certificate | 0 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized African American | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Asian/Pacific Islander | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Hispanic | 0 participants | 3 participants | 3 participants |
| Race/Ethnicity, Customized Indian | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White non-Hispanic | 22 participants | 21 participants | 43 participants |
| Region of Enrollment United States | 24 participants | 26 participants | 50 participants |
| Sex: Female, Male Female | 9 Participants | 12 Participants | 21 Participants |
| Sex: Female, Male Male | 15 Participants | 14 Participants | 29 Participants |
| Year in College Freshman | 3 participants | 5 participants | 8 participants |
| Year in College Junior | 4 participants | 7 participants | 11 participants |
| Year in College Senior | 10 participants | 8 participants | 18 participants |
| Year in College Sophomore | 7 participants | 6 participants | 13 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 2 / 24 | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Behavior Rating Inventory of Executive Function - Adult (BRIEF-A) | 65.91 T score | Standard Deviation 13.023 |
| LDX 30-mg | Behavior Rating Inventory of Executive Function - Adult (BRIEF-A) | 59.23 T score | Standard Deviation 14.088 |
| LDX 50-mg | Behavior Rating Inventory of Executive Function - Adult (BRIEF-A) | 57.64 T score | Standard Deviation 14.012 |
| LDX 70-mg | Behavior Rating Inventory of Executive Function - Adult (BRIEF-A) | 54.91 T score | Standard Deviation 13.219 |
Comparison: This was a within-subject crossover design with all participants going through a no-drug baseline followed by placebo and three dosages of LDX, with the latter four conditions in a randomly assigned, counterbalanced order. The comparison condition was the placebo condition.p-value: <0.001ANOVA
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Conners Adult ADHD Rating Scale - Short Version (CAARS) | 50.59 T score | Standard Deviation 10.975 |
| LDX 30-mg | Conners Adult ADHD Rating Scale - Short Version (CAARS) | 46.86 T score | Standard Deviation 9.939 |
| LDX 50-mg | Conners Adult ADHD Rating Scale - Short Version (CAARS) | 47.32 T score | Standard Deviation 10.092 |
| LDX 70-mg | Conners Adult ADHD Rating Scale - Short Version (CAARS) | 45.36 T score | Standard Deviation 10.79 |
Comparison: This was a within-subject crossover design with all participants going through a no-drug baseline followed by placebo and three dosages of LDX, with the latter four conditions in a randomly assigned, counterbalanced order. The comparison condition was the placebo condition.p-value: <0.001ANOVA