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

• ClinicalTrials.gov Identifier: NCT03446885
• Recruitment Status: Completed
• First Posted: February 27, 2018
• Results First Posted: June 24, 2021
• Last Update Posted: June 24, 2021
• Sponsor: Gregory Fabiano
• Information provided by (Responsible Party): Gregory Fabiano, State University of New York at Buffalo

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Attention Deficit Disorder With Hyperactivity	Drug: Lisdexamfetamine Dimesylate 40 MG; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• 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
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of Lisdexamfetamine Dimesylate for Promoting Occupational Success in Young Adults With Attention-deficit/Hyperactivity Disorder
• Actual Study Start Date: April 1, 2018
• Actual Primary Completion Date: February 11, 2019
• Actual Study Completion Date: August 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Lab visit 1; 40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion.	Drug: Lisdexamfetamine Dimesylate 40 MG; Lisdexamfetamine Dimesylate 40 MG administered orally; Drug: Placebo; Placebo capsule administered orally
Experimental: Lab visit 2; 40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion.	Drug: Lisdexamfetamine Dimesylate 40 MG; Lisdexamfetamine Dimesylate 40 MG administered orally; Drug: Placebo; Placebo capsule administered orally

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 25 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, New York

SUNY at Buffalo

Buffalo, New York, United States, 14214

Sponsors and Collaborators

Gregory Fabiano

  Study Documents (Full-Text)

Documents provided by Gregory Fabiano, State University of New York at Buffalo:

Study Protocol and Statistical Analysis Plan  [PDF] September 23, 2020

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Gregory Fabiano, Professor, State University of New York at Buffalo
• ClinicalTrials.gov Identifier: NCT03446885
• Other Study ID Numbers: IIR-USA-001277
• First Posted: February 27, 2018
• Results First Posted: June 24, 2021
• Last Update Posted: June 24, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Lisdexamfetamine Dimesylate; Central Nervous System Stimulants; Physiological Effects of Drugs; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Neurotransmitter Agents