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

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lisdexamfetamine Dimesylate 40 MG
Placebo
Sponsored by
Gregory Fabiano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity

Eligibility Criteria

16 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SUNY at Buffalo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lab visit 1

Lab visit 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 31, 2017
Last Updated
June 2, 2021
Sponsor
Gregory Fabiano
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1. Study Identification

Unique Protocol Identification Number
NCT03446885
Brief Title
Efficacy of Lisdexamfetamine Dimesylate for Promoting Occupational Success in Young Adults With ADHD
Official Title
Efficacy of Lisdexamfetamine Dimesylate for Promoting Occupational Success in Young Adults With Attention-deficit/Hyperactivity Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
February 11, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gregory Fabiano

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lab visit 1
Arm Type
Experimental
Arm Description
40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion.
Arm Title
Lab visit 2
Arm Type
Experimental
Arm Description
40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion.
Intervention Type
Drug
Intervention Name(s)
Lisdexamfetamine Dimesylate 40 MG
Intervention Description
Lisdexamfetamine Dimesylate 40 MG administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule administered orally
Primary Outcome Measure Information:
Title
Ratings of Job Application Quality
Description
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.
Time Frame
during interventional study session, 1 day in duration
Title
Ratings of Job Interview Performance
Description
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.
Time Frame
during interventional study session, 1 day in duration
Title
Objective Observation of Workplace Productivity
Description
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.
Time Frame
during interventional study session, 1 day in duration
Title
Inattentive/Overactive Rating
Description
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.
Time Frame
during interventional study session, 1 day in duration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
SUNY at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32297783
Citation
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.
Results Reference
derived

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

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