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

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ClinicalTrials.gov Identifier: NCT03446885
Recruitment Status : Not yet recruiting
First Posted : February 27, 2018
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Gregory Fabiano, State University of New York at Buffalo

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Drug: Lisdexamfetamine Dimesylate 40 MG Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Lisdexamfetamine Dimesylate for Promoting Occupational Success in Young Adults With Attention-deficit/Hyperactivity Disorder
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Lisdexamfetamine Dimesylate 40 MG
    Lisdexamfetamine Dimesylate 40 MG administered orally
  • Drug: Placebo
    Placebo capsule administered orally


Primary Outcome Measures :
  1. Ratings of Job Application Quality [ Time Frame: Change between session 1 and 2 (each session is one day in duration) ]
    Three independent coders will review each de-identified application. Following the review of the application, coders will complete a rating form that asks them to make an overall evaluation regarding whether the person was an acceptable job candidate for an interview using a scale of 1 ("definitely not") to 5 ("definitely"). Average rating across coders will be used as the dependent measure.

  2. Ratings of Job Interview Performance [ Time Frame: Change between session 1 and 2 (each session is one day in duration) ]
    Three coders who are unaware of the study participant identities or group status will view the job interview videotape and completed a form. Raters will provide a rating of their overall impression of the interview behavior ranging from a score of one (Poor) to four (Outstanding). The average score of the coders will be utilized as a dependent measure.

  3. Objective Observation of Workplace Productivity [ Time Frame: Change between session 1 and 2 (each session is one day in duration) ]
    The dependent measures from this aspect of the study are the number of items completed correctly out of the total number of assigned items (i.e., 225).

  4. Inattentive/Overactive Rating [ Time Frame: Change between session 1 and 2 (each session is one day in duration) ]
    In addition to ratings of the interview performance, the rater also will complete the five-item inattentive/overactive (I/O) factor of the Iowa Conners rating scale (Atkins, Pelham, & Licht, 1989; Loney & Milich, 1982; Pelham, Milich, Murphy, & Murphy, 1989). The five items are rated on a scale of Not at all (0) to Very Much and the sum of these items represents the score. The dependent measure will be the score averaged across raters.



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Ages Eligible for Study:   16 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03446885


Locations
United States, New York
SUNY at Buffalo Not yet recruiting
Buffalo, New York, United States, 14214
Contact: Gregory A Fabiano, PhD    716-645-1130    fabiano@buffalo.edu   
Sponsors and Collaborators
Gregory Fabiano

Responsible Party: Gregory Fabiano, Professor, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT03446885     History of Changes
Other Study ID Numbers: IIR-USA-001277
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lisdexamfetamine Dimesylate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents