Efficacy of Lisdexamfetamine Dimesylate for Promoting Occupational Success in Young Adults With Attention-deficit/Hyperactivity Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Ratings of Job Application Quality
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Lab visit 2
40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion.
干预措施: Placebo (Drug)
Lab visit 2
40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion.
干预措施: Lisdexamfetamine Dimesylate 40 MG (Drug)
Lab visit 1
40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion.
干预措施: Lisdexamfetamine Dimesylate 40 MG (Drug)
Lab visit 1
40 mg of Vyvanse administered q.a.m. or Placebo administered in random, counter-balanced fashion.
干预措施: Placebo (Drug)
结局指标
主要结局
Ratings of Job Application Quality
时间窗: during interventional study session, 1 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.
Ratings of Job Interview Performance
时间窗: during interventional study session, 1 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.
Objective Observation of Workplace Productivity
时间窗: during interventional study session, 1 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). Thus, the score reflects the percentage of items correctly completed out of the 225 assigned and scores could range from 0-100.
Inattentive/Overactive Rating
时间窗: during interventional study session, 1 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 (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.
次要结局
未报告次要终点
研究者
Gregory Fabiano
Professor
State University of New York at Buffalo