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

Gregory Fabiano

Status and phase

Completed

Phase 4

Conditions

Attention Deficit Disorder With Hyperactivity

Treatments

Drug: Lisdexamfetamine Dimesylate 40 MG

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03446885

IIR-USA-001277

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

16 to 25 years old

Volunteers

No 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