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Effects of LDX on Functioning of College Students With ADHD

Primary Purpose

Attention-deficit/Hyperactivity Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
lisdexamfetamine dimesylate
Placebo
Sponsored by
University of Rhode Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention-deficit/Hyperactivity Disorder

Eligibility Criteria

18 Years - 28 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Education and Human Services, Lehigh University
  • Department of Psychology, University of Rhode Island

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lisdexamfetamine dimesylate

Arm Description

All participants will be assessed across five conditions (baseline, placebo, 30-mg, 50-mg, & 70-mg) in a double-blind, crossover design

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Full Information

First Posted
April 21, 2011
Last Updated
April 7, 2014
Sponsor
University of Rhode Island
Collaborators
Lehigh University
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1. Study Identification

Unique Protocol Identification Number
NCT01342445
Brief Title
Effects of LDX on Functioning of College Students With ADHD
Official Title
Effects of Vyvanse on the Behavioral, Academic, and Psychosocial Functioning of College Students With ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rhode Island
Collaborators
Lehigh University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention-deficit/Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lisdexamfetamine dimesylate
Arm Type
Experimental
Arm Description
All participants will be assessed across five conditions (baseline, placebo, 30-mg, 50-mg, & 70-mg) in a double-blind, crossover design
Intervention Type
Drug
Intervention Name(s)
lisdexamfetamine dimesylate
Other Intervention Name(s)
Vyvanse, LDX
Intervention Description
30-mg, 50-mg, 70-mg administered for one week in context of double-blind, placebo-controlled crossover design
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Conners Adult ADHD Rating Scale - Short Version (CAARS)
Description
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).
Time Frame
after receiving Placebo or LDX for 1 week
Title
Behavior Rating Inventory of Executive Function - Adult (BRIEF-A)
Description
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.
Time Frame
after receiving Placebo or LDX for 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa L Weyandt, PhD
Organizational Affiliation
University of Rhode Island
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Education and Human Services, Lehigh University
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Department of Psychology, University of Rhode Island
City
Kingston
State/Province
Rhode Island
ZIP/Postal Code
02881
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22166471
Citation
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.
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Effects of LDX on Functioning of College Students With ADHD

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