Effects of LDX on Functioning of College Students With ADHD

NCT01342445 | Completed Phase 4 Results

• 1 other identifier: Shire-80000311112
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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).

Conditions

Attention-deficit/Hyperactivity Disorder

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

lisdexamfetamine dimesylate

EXPERIMENTAL

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; Drug: Placebo

Interventions

lisdexamfetamine dimesylate DRUG

30-mg, 50-mg, 70-mg administered for one week in context of double-blind, placebo-controlled crossover design

Also known as: Vyvanse, LDX

lisdexamfetamine dimesylate

Placebo DRUG

lisdexamfetamine dimesylate

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rhode Island: lead
• Lehigh University: collaborator

Study Sites (2)

Department of Education and Human Services, Lehigh University

Bethlehem, Pennsylvania, 18015, United States

Location

Department of Psychology, University of Rhode Island

Kingston, Rhode Island, 02881, United States

Location

Related 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(3):202-20. doi: 10.1177/1087054711427299. Epub 2011 Dec 12.

  PMID: 22166471 RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Limitations and Caveats

No notable limitations or caveats are noted.

Results Point of Contact

• Title: Dr. Lisa Weyandt
• Organization: University of Rhode Island

lisaweyandt@uri.edu

(401)874-2087

Study Officials

• Lisa L Weyandt, PhD

  University of Rhode Island

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 21, 2011
• First Posted: April 27, 2011
• Study Start: September 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: April 24, 2025
• Results First Posted: April 8, 2014

Record last verified: 2025-04

Locations

US (2)