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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

NCT00697515

ADHD

COMPLETED PHASE3

Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

NCT00735371

Attention Deficit Hyperactivity Disorder (ADHD)

COMPLETED PHASE3

Effects of LDX on Functioning of College Students With ADHD

NCT01342445

Attention-deficit/Hyperactivity Disorder

COMPLETED PHASE4

Lisdexamfetamine Dimesylate in the Treatment of Adult ADHD With Anxiety Disorder Comorbidity

NCT01863459

Adult Attention Deficit Hyperactivity Disorder (ADHD) With Co-occuring Anxiety and Depressive Disorders

COMPLETED PHASE4

Lisdexamfetamine Dimesylate (LDX) Pilot Cognition Study to Evaluate the Utility of a Standardized Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

NCT01010750

Attention-Deficit Hyperactivity Disorder

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Attention Deficit Disorder With Hyperactivity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lab visit 1

40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion.

Group Type EXPERIMENTAL

Lisdexamfetamine Dimesylate 40 MG

Intervention Type DRUG

Lisdexamfetamine Dimesylate 40 MG administered orally

Placebo

Intervention Type DRUG

Placebo capsule administered orally

Lab visit 2

40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion.

Group Type EXPERIMENTAL

Lisdexamfetamine Dimesylate 40 MG

Intervention Type DRUG

Lisdexamfetamine Dimesylate 40 MG administered orally

Placebo

Intervention Type DRUG

Placebo capsule administered orally

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lisdexamfetamine Dimesylate 40 MG

Lisdexamfetamine Dimesylate 40 MG administered orally

Intervention Type DRUG

Placebo

Placebo capsule administered orally

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

16 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No