Trial Outcomes & Findings for Efficacy of Lisdexamfetamine Dimesylate for Promoting Occupational Success in Young Adults With ADHD (NCT NCT03446885)

Last Updated: 2021-06-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

22 participants

Primary outcome timeframe

during interventional study session, 1 day in duration

Results posted on

2021-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Allocated to Vyvanse First Administration of Vyvanse 40 mg then placebo on different days in a cross-over design	Allocated to Placebo First Allocated to placebo then Vyvanse 40 mg on different days
Overall Study STARTED	12	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Allocated to Vyvanse First Administration of Vyvanse 40 mg then placebo on different days in a cross-over design	Allocated to Placebo First Allocated to placebo then Vyvanse 40 mg on different days
Overall Study Lost to Follow-up	1	0
Overall Study Did not complete entire visit	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ADHD Participant n=21 Participants Administration of placebo capsule/Vyvanse 40 mg on different days in a cross-over design
Age, Continuous	19.76 years STANDARD_DEVIATION 2.8 • n=93 Participants
Sex: Female, Male Female	4 Participants n=93 Participants
Sex: Female, Male Male	17 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants
Race (NIH/OMB) White	14 Participants n=93 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	21 participants n=93 Participants
Currently prescribed stimulant medication	14 Participants n=93 Participants

PRIMARY outcome

Timeframe: during interventional study session, 1 day in duration

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Placebo	Vyvanse n=20 Participants 40 mg Vyvanse
Ratings of Job Application Quality	3.40 score on a scale Standard Deviation 1.03	3.56 score on a scale Standard Deviation 1.00

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Placebo	Vyvanse n=20 Participants 40 mg Vyvanse
Ratings of Job Interview Performance	3.17 score on a scale Standard Deviation .76	3.33 score on a scale Standard Deviation .91

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Placebo	Vyvanse n=20 Participants 40 mg Vyvanse
Objective Observation of Workplace Productivity	65.60 score on a scale Standard Deviation 17.55	68.45 score on a scale Standard Deviation 15.60

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=20 Participants Placebo	Vyvanse n=20 Participants 40 mg Vyvanse
Inattentive/Overactive Rating	2.13 score on a scale Standard Deviation 1.33	2.01 score on a scale Standard Deviation 1.28

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vyvanse

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gregory A. Fabiano, Ph.D.

Florida International University

Phone: 716-359-7823

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place