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Completed

NCT Number: NCT01342445

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).

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Key information

Conditions

Attention-Deficit/Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Education and Human Services, Lehigh University, Bethlehem, Pennsylvania, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lisdexamfetamine dimesylate

Drug

30-mg, 50-mg, 70-mg administered for one week in context of double-blind, placebo-controlled crossover design

Other names: Vyvanse, LDX

Placebo

Drug

Primary outcomes

  1. Conners Adult ADHD Rating Scale - Short Version (CAARS)

    Time frame: 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).

  2. Behavior Rating Inventory of Executive Function - Adult (BRIEF-A)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Rhode Island

Other

Collaborators

  • Lehigh University

Registry information

Official study title

Effects of Vyvanse on the Behavioral, Academic, and Psychosocial Functioning of College Students With ADHD

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 27, 2011
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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