Efficacy of Lisdexamfetamine Dimesylate for Promoting Occupational Success in Young Adults With ADHD
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Lisdexamfetamine Dimesylate 40 MG; Placebo
Intervention description: Lisdexamfetamine Dimesylate 40 MG administered orally; Placebo capsule administered orally
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
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
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 16 Years
Maximum age: 25 Years
Healthy volunteers: No

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