Effects of LDX on Functioning of College Students With ADHD

Attention-deficit/Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01342445
• Other study ID #: Shire-80000311112
• Status: Completed
• Phase: Phase 4
• First received: April 21, 2011
• Last updated: April 7, 2014
• Start date: September 2009
• Est. completion date: December 2010

Study information

• Verified date: March 2014
• Source: University of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 28 Years

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention-deficit/Hyperactivity Disorder

Intervention

Drug:
• lisdexamfetamine dimesylate
30-mg, 50-mg, 70-mg administered for one week in context of double-blind, placebo-controlled crossover design
• Placebo

Locations

Country	Name	City	State
United States	Department of Education and Human Services, Lehigh University	Bethlehem	Pennsylvania
United States	Department of Psychology, University of Rhode Island	Kingston	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
University of Rhode Island	Lehigh University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conners Adult ADHD Rating Scale - Short Version (CAARS)	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).	after receiving Placebo or LDX for 1 week	No
Primary	Behavior Rating Inventory of Executive Function - Adult (BRIEF-A)	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.	after receiving Placebo or LDX for 1 week	No