Phase 4
N=22
Efficacy of Lisdexamfetamine Dimesylate for Promoting Occupational Success in Young Adults With ADHD
Attention Deficit Disorder With Hyperactivity
Bottom Line
View on ClinicalTrials.gov: NCT03446885 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Ratings of Job Application Quality — 3.40; 3.56 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lisdexamfetamine Dimesylate 40 MG (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- Gregory Fabiano
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ratings of Job Application Quality |
3.40; 3.56 | — |
| PRIMARY Ratings of Job Interview Performance |
3.17; 3.33 | — |
| PRIMARY Objective Observation of Workplace Productivity |
65.60; 68.45 | — |
| PRIMARY Inattentive/Overactive Rating |
2.13; 2.01 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03446885). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.