Attention Deficit Disorder With Hyperactivity
Conditions
Brief summary
There has been little research on the third area of impairment noted in the Diagnostic and Statistical Manual of Mental Disorders - occupational functioning. Individuals with ADHD experience job-related impairments including a greater likelihood of being unemployed and not enrolled in school and for those that were employed they were in a lower status occupation, relative to typically-developing comparison peers. The current literature on analogue workplace settings and the effects of lisdexamfetamine dimesylate includes office-based tasks similar to school seat work. Unfortunately, this is inconsistent with the typical work environment most common for individuals with disabilities such as ADHD where food preparation is the most common job following high school. Therefore, medication effects in this type of setting, most common for individuals with ADHD entering the workforce, need to be studied. The investigators propose to study workplace behavior in an analogue work setting in a laboratory pizza place. Individuals with ADHD will participate in an interview with a supervisor each day, have a list of deliveries that need to be managed, deal with situations that require occupational judgment and appropriate customer service, and drive to make deliveries accurately and on-time. These behaviors can be reliably assessed within the laboratory. Twenty young adults will participate in two workdays within a randomized, double-blind, placebo-controlled design wherein participants will be administered placebo and .3 mg/kg lisdexamfetamine dimesylate in a counter-balanced order.
Interventions
DRUGLisdexamfetamine Dimesylate 40 MG
Lisdexamfetamine Dimesylate 40 MG administered orally
DRUGPlacebo
Placebo capsule administered orally
Sponsors
Gregory Fabiano
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
All participants received placebo and 40 mg Vyvanse in a cross-over design. Order of administration was randomly assigned and counter-balanced across participants
Eligibility
Sex/Gender
ALL
Age
16 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of ADHD * parental permission and/or teen consent/assent as appropriate * between 16-25 years of age * IQ greater than or equal to 70 * permit or license to drive * ability to read and understand English
Exclusion criteria
* any medical condition that would contraindicate use of stimulant medication * any prior adverse response to lisdexamfetamine dimesylate or other stimulant medication * use of concurrent,non-stimulant psychoactive medication * diagnosis of schizophrenia or presence of thought disorder symptoms * autism spectrum disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratings of Job Application Quality | during interventional study session, 1 day in duration | Three independent coders will review each de-identified application. Following the review of the application, coders will complete a rating form that asks them to make an overall evaluation regarding whether the person was an acceptable job candidate for an interview using a scale of 1 (definitely not) to 5 (definitely). Average rating across coders will be used as the dependent measure. |
| Ratings of Job Interview Performance | during interventional study session, 1 day in duration | Three coders who are unaware of the study participant identities or group status will view the job interview videotape and completed a form. Raters will provide a rating of their overall impression of the interview behavior ranging from a score of one (Poor) to four (Outstanding). The average score of the coders will be utilized as a dependent measure. |
| Objective Observation of Workplace Productivity | during interventional study session, 1 day in duration | The dependent measures from this aspect of the study are the number of items completed correctly out of the total number of assigned items (i.e., 225). Thus, the score reflects the percentage of items correctly completed out of the 225 assigned and scores could range from 0-100. |
| Inattentive/Overactive Rating | during interventional study session, 1 day in duration | In addition to ratings of the interview performance, the rater also will complete the five-item inattentive/overactive (I/O) factor of the Iowa Conners rating scale (Atkins, Pelham, & Licht, 1989; Loney & Milich, 1982; Pelham, Milich, Murphy, & Murphy, 1989). The five items are rated on a scale of Not at all (0) to Very Much (3) and the sum of these items represents the score. The dependent measure will be the score averaged across raters. Scores can range from 0-3 on each item, and the average score of the 5 items was used. Higher scores reflect greater inattentive/overactivity-related behaviors. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ADHD Participant Administration of placebo capsule/Vyvanse 40 mg on different days in a cross-over design | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not complete entire visit | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | ADHD Participant |
|---|---|
| Age, Continuous | 19.76 years STANDARD_DEVIATION 2.8 |
| Currently prescribed stimulant medication | 14 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Inattentive/Overactive Rating
In addition to ratings of the interview performance, the rater also will complete the five-item inattentive/overactive (I/O) factor of the Iowa Conners rating scale (Atkins, Pelham, & Licht, 1989; Loney & Milich, 1982; Pelham, Milich, Murphy, & Murphy, 1989). The five items are rated on a scale of Not at all (0) to Very Much (3) and the sum of these items represents the score. The dependent measure will be the score averaged across raters. Scores can range from 0-3 on each item, and the average score of the 5 items was used. Higher scores reflect greater inattentive/overactivity-related behaviors.
Time frame: during interventional study session, 1 day in duration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Inattentive/Overactive Rating | 2.13 score on a scale | Standard Deviation 1.33 |
| Vyvanse | Inattentive/Overactive Rating | 2.01 score on a scale | Standard Deviation 1.28 |
Primary
Objective Observation of Workplace Productivity
The dependent measures from this aspect of the study are the number of items completed correctly out of the total number of assigned items (i.e., 225). Thus, the score reflects the percentage of items correctly completed out of the 225 assigned and scores could range from 0-100.
Time frame: during interventional study session, 1 day in duration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Objective Observation of Workplace Productivity | 65.60 score on a scale | Standard Deviation 17.55 |
| Vyvanse | Objective Observation of Workplace Productivity | 68.45 score on a scale | Standard Deviation 15.6 |
Primary
Ratings of Job Application Quality
Three independent coders will review each de-identified application. Following the review of the application, coders will complete a rating form that asks them to make an overall evaluation regarding whether the person was an acceptable job candidate for an interview using a scale of 1 (definitely not) to 5 (definitely). Average rating across coders will be used as the dependent measure.
Time frame: during interventional study session, 1 day in duration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Ratings of Job Application Quality | 3.40 score on a scale | Standard Deviation 1.03 |
| Vyvanse | Ratings of Job Application Quality | 3.56 score on a scale | Standard Deviation 1 |
Primary
Ratings of Job Interview Performance
Three coders who are unaware of the study participant identities or group status will view the job interview videotape and completed a form. Raters will provide a rating of their overall impression of the interview behavior ranging from a score of one (Poor) to four (Outstanding). The average score of the coders will be utilized as a dependent measure.
Time frame: during interventional study session, 1 day in duration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Ratings of Job Interview Performance | 3.17 score on a scale | Standard Deviation 0.76 |
| Vyvanse | Ratings of Job Interview Performance | 3.33 score on a scale | Standard Deviation 0.91 |