Clinical trial NCT03446885: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 22
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Ratings of Job Application Quality
timeFrame: during interventional study session, 1 day in duration
measure: Ratings of Job Interview Performance
timeFrame: during interventional study session, 1 day in duration
measure: Objective Observation of Workplace Productivity
timeFrame: during interventional study session, 1 day in duration
measure: Inattentive/Overactive Rating
timeFrame: during interventional study session, 1 day in duration
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: SUNY at Buffalo
state: New York
Study officials:
References:
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.