CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 22 enrolled
Drug / intervention
Lisdexamfetamine Dimesylate 40 MG +1 moredrug
Likely dose
Lisdexamfetamine Dimesylate 40 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03446885
NCT03446885Phase 4Completed

Efficacy of Lisdexamfetamine Dimesylate for Promoting Occupational Success in Young Adults With Attention-deficit/Hyperactivity Disorder

Gregory Fabiano·interventional·Posted Feb 27, 2018·Updated Jun 24, 2021

In Brief

A Phase 4 clinical trial evaluating Lisdexamfetamine Dimesylate 40 MG and Placebo for Attention Deficit Disorder With Hyperactivity. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedFeb 27, 2018
Enrollment StartApr 1, 2018
Primary CompletionFeb 11, 2019
Study CompletionAug 30, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 8.3 years ago

Interventions

Lisdexamfetamine Dimesylate 40 MGdrug

Lisdexamfetamine Dimesylate 40 MG administered orally

Placebodrug

Placebo capsule administered orally