Clinical trial NCT01342445: Effects of LDX on Functioning of College Students With ADHD
Official title: Effects of Vyvanse on the Behavioral, Academic, and Psychosocial Functioning of College Students With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention-deficit/Hyperactivity Disorder
Lead sponsor: University of Rhode Island
Sponsor class: OTHER
Collaborators: name: Lehigh University
First posted: 2011-04-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Conners Adult ADHD Rating Scale - Short Version (CAARS)
timeFrame: after receiving Placebo or LDX for 1 week
measure: Behavior Rating Inventory of Executive Function - Adult (BRIEF-A)
timeFrame: after receiving Placebo or LDX for 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: Department of Education and Human Services, Lehigh University
state: Pennsylvania
city: Kingston
country: United States
facility: Department of Psychology, University of Rhode Island
state: Rhode Island
Study officials:
affiliation: University of Rhode Island
name: Lisa L Weyandt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dupaul GJ, Weyandt LL, Rossi JS, Vilardo BA, O'Dell SM, Carson KM, Verdi G, Swentosky A. Double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in college students with ADHD. J Atten Disord. 2012 Apr;16(3):202-20. doi: 10.1177/1087054711427299. Epub 2011 Dec 12.