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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lab visit 1 | Experimental | 40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion. |
|
| Lab visit 2 | Experimental | 40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lisdexamfetamine Dimesylate 40 MG | Drug | Lisdexamfetamine Dimesylate 40 MG administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ratings of Job Application Quality | 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. | during interventional study session, 1 day in duration |
| Ratings of Job Interview Performance | 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. | during interventional study session, 1 day in duration |
| Objective Observation of Workplace Productivity | 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). Thus, the score reflects the percentage of items correctly completed out of the 225 assigned and scores could range from 0-100. | during interventional study session, 1 day in duration |
| Inattentive/Overactive Rating | 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 (3) and the sum of these items represents the score. The dependent measure will be the score averaged across raters. Scores can range from 0-3 on each item, and the average score of the 5 items was used. Higher scores reflect greater inattentive/overactivity-related behaviors. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SUNY at Buffalo | Buffalo | New York | 14214 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32297783 | Derived | Gordon CT, Fabiano GA, Hulme KF, Sodano SM, Adragna M, Lim R, Stanford S, Janikowski L, Bufalo B, Rodriguez Z, Swiatek D. Efficacy of lisdexamfetamine dimesylate for promoting occupational success in adolescents and young adults with attention-deficit/hyperactivity disorder. Exp Clin Psychopharmacol. 2021 Aug;29(4):308-318. doi: 10.1037/pha0000365. Epub 2020 Apr 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Allocated to Vyvanse First | Administration of Vyvanse 40 mg then placebo on different days in a cross-over design |
| FG001 | Allocated to Placebo First | Allocated to placebo then Vyvanse 40 mg on different days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ADHD Participant | Administration of placebo capsule/Vyvanse 40 mg on different days in a cross-over design |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ratings of Job Application Quality | 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. | Posted | Mean | Standard Deviation | score on a scale | during interventional study session, 1 day in duration |
|
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.
The definition was not different from clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory A. Fabiano, Ph.D. | Florida International University | 716-359-7823 | gfabiano@fiu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 23, 2020 | Sep 23, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
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All participants received placebo and 40 mg Vyvanse in a cross-over design. Order of administration was randomly assigned and counter-balanced across participants
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| Placebo | Drug | Placebo capsule administered orally |
|
| during interventional study session, 1 day in duration |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Currently prescribed stimulant medication | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Ratings of Job Interview Performance | 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. | Posted | Mean | Standard Deviation | score on a scale | during interventional study session, 1 day in duration |
|
|
|
| Primary | Objective Observation of Workplace Productivity | 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). Thus, the score reflects the percentage of items correctly completed out of the 225 assigned and scores could range from 0-100. | Posted | Mean | Standard Deviation | score on a scale | during interventional study session, 1 day in duration |
|
|
|
| Primary | Inattentive/Overactive Rating | 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 (3) and the sum of these items represents the score. The dependent measure will be the score averaged across raters. Scores can range from 0-3 on each item, and the average score of the 5 items was used. Higher scores reflect greater inattentive/overactivity-related behaviors. | Posted | Mean | Standard Deviation | score on a scale | during interventional study session, 1 day in duration |
|
|
|
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Vyvanse | 40 mg Vyvanse | 0 | 20 | 0 | 20 | 0 | 20 |
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| D005021 |
| Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |