Effects of LDX on Functioning of College Students With ADHD
The purpose of this study was to evaluate the effects of lisdexamfetamine dimesylate, a prodrug stimulant, on the behavioral, academic, and psychosocial functioning of college students with attention-deficit/hyperactivity disorder (ADHD). Twenty-five college students with ADHD from two universities (University of Rhode Island and Lehigh University) completed a within-subject, placebo-controlled research trial. Dependent measures tapping behavioral, psychosocial, and academic functioning were completed on a weekly basis across five conditions (baseline, placebo, and 30-mg, 50-mg, and 70-mg lisdexamfetamine).
Drug: lisdexamfetamine dimesylate
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effects of Vyvanse on the Behavioral, Academic, and Psychosocial Functioning of College Students With ADHD|
- Conners Adult ADHD Rating Scale - Short Version (CAARS) [ Time Frame: after receiving Placebo or LDX for 1 week ] [ Designated as safety issue: No ]CAARS ADHD Index, adult self-report measure of ADHD symptoms. T-scores (mean = 50; standard deviation = 10) for all subscales on the short version were used as dependent measures with higher scores representing greater ADHD symptomatology (and ultimately a worse outcome in this study).
- Behavior Rating Inventory of Executive Function - Adult (BRIEF-A) [ Time Frame: after receiving Placebo or LDX for 1 week ] [ Designated as safety issue: No ]BRIEF-A is a standardized self-report measure that captures adults' views of their own self-regulation in their everyday environment. Metacognition Index T-scores (mean = 50; standard deviation = 10) were used as dependent measures with higher scores representing greater deficit in planning/organizational skills critical for college success.
|Study Start Date:||September 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Experimental: lisdexamfetamine dimesylate
All participants will be assessed across five conditions (baseline, placebo, 30-mg, 50-mg, & 70-mg) in a double-blind, crossover design
Drug: lisdexamfetamine dimesylate
30-mg, 50-mg, 70-mg administered for one week in context of double-blind, placebo-controlled crossover design
Other Names:Drug: Placebo
Objective: Evaluate stimulant medication on symptoms and functioning for college students with ADHD using double-blind, placebo-controlled, crossover design. Method: Participants included 24 college students with ADHD and 26 college students without psychopathology. Lisdexamfetamine dimesylate (LDX) examined for ADHD participants over five weekly phases (no-drug baseline, placebo, 30, 50, & 70-mg LDX per day). Self-report rating scales of functioning and direct assessment of ADHD symptoms, verbal learning/memory, and adverse side-effects were collected (baseline only for control students).
|United States, Pennsylvania|
|Department of Education and Human Services, Lehigh University|
|Bethlehem, Pennsylvania, United States, 18015|
|United States, Rhode Island|
|Department of Psychology, University of Rhode Island|
|Kingston, Rhode Island, United States, 02881|
|Principal Investigator:||Lisa L Weyandt, PhD||University of Rhode Island|