Effects of Lisdexamfetamine Dimesylate on the Functioning of College Students With Attention-deficit/Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
Collaborator:
Lehigh University
Information provided by:
University of Rhode Island
ClinicalTrials.gov Identifier:
NCT01342445
First received: April 21, 2011
Last updated: April 26, 2011
Last verified: April 2011

April 21, 2011
April 26, 2011
September 2009
December 2010   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01342445 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effects of Lisdexamfetamine Dimesylate on the Functioning of College Students With Attention-deficit/Hyperactivity Disorder (ADHD)
Effects of Vyvanse on the Behavioral, Academic, and Psychosocial Functioning of College Students With ADHD

The purpose of this study is 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) will complete a within-subject, placebo-controlled research trial. Dependent measures tapping behavioral, psychosocial, and academic functioning will be completed on a weekly basis across five conditions (baseline, placebo, and 30-mg, 50-mg, and 70-mg lisdexamfetamine).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover 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 Name: Vyvanse
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
Intervention: Drug: lisdexamfetamine dimesylate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 L. Weyandt, Ph.D., Professor of Psychology, University of Rhode Island
University of Rhode Island
Lehigh University
Principal Investigator: Lisa L Weyandt, PhD University of Rhode Island
University of Rhode Island
April 2011

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