Efficacy of Lisdexamfetamine Dimesylate for Promoting Occupational Success in Young Adults With ADHD

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Lisdexamfetamine Dimesylate for Promoting Occupational Success in Young Adults With Attention-deficit/Hyperactivity Disorder

Conditions
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Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
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* Drug: Lisdexamfetamine Dimesylate 40 MG
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lab visit 1<br>40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion. | Drug: Lisdexamfetamine Dimesylate 40 MG<br>* Lisdexamfetamine Dimesylate 40 MG administered orally<br>Drug: Placebo<br>* Placebo capsule administered orally<br>|
| Experimental: Lab visit 2<br>40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion. | Drug: Lisdexamfetamine Dimesylate 40 MG<br>* Lisdexamfetamine Dimesylate 40 MG administered orally<br>Drug: Placebo<br>* Placebo capsule administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | during interventional study session, 1 day in duration | 
| 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. | during interventional study session, 1 day in duration | 
| 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. | during interventional study session, 1 day in duration | 
| 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. | during interventional study session, 1 day in duration |