Effects of LDX on Functioning of College Students With ADHD

This study has been completed.
Sponsor:
Collaborator:
Lehigh University
Information provided by (Responsible Party):
Lisa Weyandt, University of Rhode Island
ClinicalTrials.gov Identifier:
NCT01342445
First received: April 21, 2011
Last updated: April 7, 2014
Last verified: March 2014

April 21, 2011
April 7, 2014
September 2009
December 2010   (final data collection date for primary outcome measure)
  • Conners Adult ADHD Rating Scale - Short Version (CAARS) [ Time Frame: after receiving Placebo or LDX for 1 week ] [ Designated as safety issue: No ]
    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) [ Time Frame: after receiving Placebo or LDX for 1 week ] [ Designated as safety issue: No ]
    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.
Conners Adult ADHD Rating Scale [ Time Frame: Participants will complete this measure once per week for the five consecutive weeks that they are enrolled in the study ] [ Designated as safety issue: No ]
Adult self-report measure of ADHD symptoms
Complete list of historical versions of study NCT01342445 on ClinicalTrials.gov Archive Site
Not Provided
  • Behavior Rating Inventory of Executive Function-Adult Version [ Time Frame: Participants will complete this measure once per week for the five consecutive weeks that they are enrolled in the study ] [ Designated as safety issue: No ]
  • Side-Effects Rating Scale [ Time Frame: Participants will complete this measure once per week for the five consecutive weeks that they are enrolled in the study ] [ Designated as safety issue: Yes ]
    Self-report of possible adverse events associated with placebo or active dosage of lisdexamfetamine
  • Social Adjustment Scale-Self-Report [ Time Frame: Participants will complete this measure once per week for the five consecutive weeks that they are enrolled in the study ] [ Designated as safety issue: No ]
    Self-report of social functioning
  • Conners Continuous Performance Test [ Time Frame: Participants will complete this measure once per week for the five consecutive weeks that they are enrolled in the study ] [ Designated as safety issue: No ]
    Direct assessment of sustained attention and impulse control
  • Self-report of study and organizational skills [ Time Frame: Participants will complete this measure once per week for the five consecutive weeks that they are enrolled in the study ] [ Designated as safety issue: No ]
  • Self-report of alcohol and illicit drug use [ Time Frame: Participants will complete this measure once per week for the five consecutive weeks that they are enrolled in the study ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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).

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).

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Attention-deficit/Hyperactivity Disorder
  • 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
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
Interventions:
  • Drug: lisdexamfetamine dimesylate
  • Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 28 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01342445
Shire-80000311112
No
Lisa Weyandt, University of Rhode Island
University of Rhode Island
Lehigh University
Principal Investigator: Lisa L Weyandt, PhD University of Rhode Island
University of Rhode Island
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP