Skip to main content
OpenTrials
Completed

NCT Number: NCT03446885

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

16 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

SUNY at Buffalo

Buffalo, New York, 14214, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lisdexamfetamine Dimesylate 40 MG

Drug

Lisdexamfetamine Dimesylate 40 MG administered orally

Placebo

Drug

Placebo capsule administered orally

Primary outcomes

  1. Ratings of Job Application Quality

    Time frame: 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.

  2. Ratings of Job Interview Performance

    Time frame: 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.

  3. Objective Observation of Workplace Productivity

    Time frame: 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.

  4. Inattentive/Overactive Rating

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gregory Fabiano

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 27, 2018
Registry last updated
Jun 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.