Efficacy of Lisdexamfetamine Dimesylate for Promoting Occupational Success in Young Adults With Attention-deficit/Hyperactivity Disorder
| Registry | NCT03446885 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, crossover, masking: triple, treatment |
| Enrollment | 22 (Actual) |
| Sponsor | Gregory Fabiano (Other) |
| Conditions | Attention Deficit Disorder With Hyperactivity |
| Interventions | Lisdexamfetamine Dimesylate 40 MG, Placebo (Drug) |
| Dates | start 2018-04-01, primary completion 2019-02-11, completion 2019-08-30, first posted 2018-02-27, last updated 2021-06-24 |
| Locations | 1 site in United States |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Lab visit 1 | Experimental | Drug: Lisdexamfetamine Dimesylate 40 MG; Drug: Placebo | 40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion. |
| Lab visit 2 | Experimental | Drug: Lisdexamfetamine Dimesylate 40 MG; Drug: Placebo | 40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion. |
Sex: All, ages: 16 Years to 25 Years
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
| Milestone | Allocated to Vyvanse First | Allocated to Placebo First |
|---|---|---|
| Started | 12 | 10 |
| Completed | 10 | 10 |
| Not completed | 2 | 0 |
Time frame: Each condition in the study (i.e., placebo, Vyvanse) was administered on a single day, approximately one week apart, for each participant. Adverse events were evaluated for the day of administration of each condition.
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Placebo | 0/20 (0.0%) | 0/20 (0.0%) | 0/20 (0.0%) |
| Vyvanse | 0/20 (0.0%) | 0/20 (0.0%) | 0/20 (0.0%) |
| Facility | City | Country | Status |
|---|---|---|---|
| SUNY at Buffalo | Buffalo, New York | United States |