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

NCT03446885 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IIR-USA-001277
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Lab visit 1

EXPERIMENTAL

40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion.

Drug: Lisdexamfetamine Dimesylate 40 MG; Drug: Placebo

Lab visit 2

EXPERIMENTAL

40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion.

Drug: Lisdexamfetamine Dimesylate 40 MG; Drug: Placebo

Interventions

Lisdexamfetamine Dimesylate 40 MG DRUG

Lisdexamfetamine Dimesylate 40 MG administered orally

Lab visit 1; Lab visit 2

Placebo DRUG

Placebo capsule administered orally

Lab visit 1; Lab visit 2

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gregory Fabiano: lead

Study Sites (1)

SUNY at Buffalo

Buffalo, New York, 14214, United States

Location

Related Publications (1)

• Gordon CT, Fabiano GA, Hulme KF, Sodano SM, Adragna M, Lim R, Stanford S, Janikowski L, Bufalo B, Rodriguez Z, Swiatek D. Efficacy of lisdexamfetamine dimesylate for promoting occupational success in adolescents and young adults with attention-deficit/hyperactivity disorder. Exp Clin Psychopharmacol. 2021 Aug;29(4):308-318. doi: 10.1037/pha0000365. Epub 2020 Apr 16.

  PMID: 32297783 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Gregory A. Fabiano, Ph.D.
• Organization: Florida International University

gfabiano@fiu.edu

716-359-7823

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: All participants received placebo and 40 mg Vyvanse in a cross-over design. Order of administration was randomly assigned and counter-balanced across participants

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: February 27, 2018
• Study Start: April 1, 2018
• Primary Completion: February 11, 2019
• Study Completion: August 30, 2019
• Last Updated: June 24, 2021
• Results First Posted: June 24, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)