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

• Sponsor: Gregory Fabiano (Other)
• Overall Status: Completed
• CT.gov ID: NCT03446885
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arms: 2
• Actual Duration (Months): 17
• Patients Per Site Per Month: 1.3

Study Details

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
• 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 participantsAll 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: Apr 1, 2018
• Actual Primary Completion Date: Feb 11, 2019
• Actual Study Completion Date: Aug 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 [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 [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 [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 [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

Criteria

• Ages Eligible for Study: 16 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	SUNY at Buffalo	Buffalo	New York	United States	14214

Sponsors and Collaborators

• Gregory Fabiano

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 23, 2020

More Information

Publications

None provided.

• 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: Feb 27, 2018
• Last Update Posted: Jun 24, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• 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; Lisdexamfetamine Dimesylate

Study Results

Participant Flow

Arm/Group Title	Allocated to Vyvanse First	Allocated to Placebo First
Arm/Group Description	Administration of Vyvanse 40 mg then placebo on different days in a cross-over design	Allocated to placebo then Vyvanse 40 mg on different days
Period Title: Overall Study
STARTED	12	10
COMPLETED	10	10
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	ADHD Participant
Arm/Group Description	Administration of placebo capsule/Vyvanse 40 mg on different days in a cross-over design
Overall Participants	21
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	19.76 (2.8)
Sex: Female, Male (Count of Participants)
Female	4 19%
Male	17 81%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 14.3%
Not Hispanic or Latino	18 85.7%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 4.8%
Asian	2 9.5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	3 14.3%
White	14 66.7%
More than one race	1 4.8%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	21 100%
Currently prescribed stimulant medication (Count of Participants)
Count of Participants [Participants]	14 66.7%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Vyvanse
Arm/Group Description	Placebo	40 mg Vyvanse
Measure Participants	20	20
Mean (Standard Deviation) [score on a scale]	3.40 (1.03)	3.56 (1.00)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Vyvanse
Arm/Group Description	40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion. Lisdexamfetamine Dimesylate 40 MG: Lisdexamfetamine Dimesylate 40 MG administered orally Placebo: Placebo capsule administered orally	40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion. Lisdexamfetamine Dimesylate 40 MG: Lisdexamfetamine Dimesylate 40 MG administered orally Placebo: Placebo capsule administered orally
Measure Participants	20	20
Mean (Standard Deviation) [score on a scale]	3.17 (.76)	3.33 (.91)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Vyvanse
Arm/Group Description	40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion. Lisdexamfetamine Dimesylate 40 MG: Lisdexamfetamine Dimesylate 40 MG administered orally Placebo: Placebo capsule administered orally	40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion. Lisdexamfetamine Dimesylate 40 MG: Lisdexamfetamine Dimesylate 40 MG administered orally Placebo: Placebo capsule administered orally
Measure Participants	20	20
Mean (Standard Deviation) [score on a scale]	65.60 (17.55)	68.45 (15.60)

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Vyvanse
Arm/Group Description	40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion. Lisdexamfetamine Dimesylate 40 MG: Lisdexamfetamine Dimesylate 40 MG administered orally Placebo: Placebo capsule administered orally	40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion. Lisdexamfetamine Dimesylate 40 MG: Lisdexamfetamine Dimesylate 40 MG administered orally Placebo: Placebo capsule administered orally
Measure Participants	20	20
Mean (Standard Deviation) [score on a scale]	2.13 (1.33)	2.01 (1.28)

Adverse Events

Time Frame	Each condition in the study (i.e., placebo, Vyvanse) was administered on a single day, approximately one week apart, for each participant. Adverse events were evaluated for the day of administration of each condition.
Adverse Event Reporting Description	The definition was not different from clinicaltrials.gov definitions.
Arm/Group Title	Placebo		Vyvanse
Arm/Group Description	Placebo		40 mg Vyvanse
All Cause Mortality
	Placebo		Vyvanse
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Placebo		Vyvanse
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Vyvanse
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.