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

Purpose

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).

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover 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:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Lisdexamfetamine Lisdexamfetamine dimesylate

U.S. FDA Resources

Further study details as provided by University of Rhode Island:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	24
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 Name: Vyvanse

Eligibility

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

Criteria

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

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

No publications provided

Responsible Party:	Lisa L. Weyandt, Ph.D., Professor of Psychology, University of Rhode Island
ClinicalTrials.gov Identifier:	NCT01342445 History of Changes
Other Study ID Numbers:	Shire-80000311112
Study First Received:	April 21, 2011
Last Updated:	April 26, 2011
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 June 18, 2013