Effects of LDX on Functioning of College Students With ADHD

Phase 4

Completed

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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
lisdexamfetamine dimesylate	Placebo	All participants will be assessed across five conditions (baseline, placebo, 30-mg, 50-mg, \& 70-mg) in a double-blind, crossover design
lisdexamfetamine dimesylate	lisdexamfetamine dimesylate	All participants will be assessed across five conditions (baseline, placebo, 30-mg, 50-mg, \& 70-mg) in a double-blind, crossover design

Primary Outcome Measures

Name	Time	Method
Conners Adult ADHD Rating Scale - Short Version (CAARS)	after receiving Placebo or LDX for 1 week	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)	after receiving Placebo or LDX for 1 week	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.

Secondary Outcome Measures

Name	Time	Method

Locations (2): Department of Psychology, University of Rhode Island
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Kingston, Rhode Island, United States
Department of Education and Human Services, Lehigh University
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Bethlehem, Pennsylvania, United States