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
|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|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
- Drug: Lisdexamfetamine Dimesylate 40 MG
Lisdexamfetamine Dimesylate 40 MG administered orally
- Drug: Placebo
Placebo capsule administered orally
- 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.
- 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.
- 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).
- 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.
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
|United States, New York|
|SUNY at Buffalo||Not yet recruiting|
|Buffalo, New York, United States, 14214|
|Contact: Gregory A Fabiano, PhD 716-645-1130 email@example.com|