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

Phase 4

Completed

Conditions: Attention Deficit Disorder With Hyperactivity

Interventions: Drug: Lisdexamfetamine Dimesylate 40 MG
Drug: Placebo

Registration Number: NCT03446885

Lead Sponsor: Gregory Fabiano

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 22

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lab visit 1	Placebo	40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion.
Lab visit 2	Placebo	40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion.
Lab visit 2	Lisdexamfetamine Dimesylate 40 MG	40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion.
Lab visit 1	Lisdexamfetamine Dimesylate 40 MG	40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion.

Primary Outcome Measures

Name	Time	Method
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.