Effects of LDX on Functioning of College Students With ADHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01342445
Recruitment Status : Completed
First Posted : April 27, 2011
Results First Posted : April 8, 2014
Last Update Posted : April 8, 2014
Lehigh University
Information provided by (Responsible Party):
Lisa Weyandt, University of Rhode Island

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).

Condition or disease Intervention/treatment Phase
Attention-deficit/Hyperactivity Disorder Drug: lisdexamfetamine dimesylate Drug: Placebo Phase 4

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Vyvanse on the Behavioral, Academic, and Psychosocial Functioning of College Students With ADHD
Study Start Date : September 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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:
  • Vyvanse
  • LDX

Drug: Placebo

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 28 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01342445

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
Sponsors and Collaborators
University of Rhode Island
Lehigh University
Principal Investigator: Lisa L Weyandt, PhD University of Rhode Island

Publications of Results:
Responsible Party: Lisa Weyandt, Professor, University of Rhode Island Identifier: NCT01342445     History of Changes
Other Study ID Numbers: Shire-80000311112
First Posted: April 27, 2011    Key Record Dates
Results First Posted: April 8, 2014
Last Update Posted: April 8, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Lisdexamfetamine Dimesylate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents