Title
Effects of LDX on Functioning of College Students With ADHD
Effects of Vyvanse on the Behavioral, Academic, and Psychosocial Functioning of College Students With ADHD
Phase
Phase 4Lead Sponsor
University of Rhode IslandStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Attention-deficit/Hyperactivity DisorderIntervention/Treatment
lisdexamfetamine ...Study Participants
50The 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).
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).
30-mg, 50-mg, 70-mg administered for one week in context of double-blind, placebo-controlled crossover design
All participants will be assessed across five conditions (baseline, placebo, 30-mg, 50-mg, & 70-mg) in a double-blind, crossover design
Inclusion Criteria: Diagnostic Statistical Manual of Mental Disorders 4th edition-text revision (DSM-IV-TR) criteria for ADHD based on self- and parent-report using questionnaires and clinical interview Exclusion Criteria: significant cardiac condition based on medical history and/or physical examination significant substance abuse based on self-report and toxicology screen at intake significant symptoms of major depressive disorder, bipolar disorder, or thought disorder based on initial diagnostic interview
| Event Type | Organ System | Event Term | Placebo | LDX 30-mg | LDX 50-mg | LDX 70-mg |
|---|
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).
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.
