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
  Purpose

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 Intervention Phase
Attention-deficit/Hyperactivity Disorder
Drug: lisdexamfetamine dimesylate
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Vyvanse on the Behavioral, Academic, and Psychosocial Functioning of College Students With ADHD

Resource links provided by NLM:


Further study details as provided by University of Rhode Island:

Primary Outcome Measures:
  • 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.


Enrollment: 50
Study Start Date: September 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 28 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342445

Locations
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
Investigators
Principal Investigator: Lisa L Weyandt, PhD University of Rhode Island
  More Information

Publications:
Responsible Party: Lisa Weyandt, Professor, University of Rhode Island
ClinicalTrials.gov Identifier: NCT01342445     History of Changes
Other Study ID Numbers: Shire-80000311112
Study First Received: April 21, 2011
Results First Received: August 6, 2013
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dextroamphetamine
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014