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Effects of LDX on Functioning of College Students With ADHD

Information source: University of Rhode Island
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention-deficit/Hyperactivity Disorder

Intervention: lisdexamfetamine dimesylate (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Rhode Island

Official(s) and/or principal investigator(s):
Lisa L Weyandt, PhD, Principal Investigator, Affiliation: University of Rhode Island

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).

Clinical Details

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

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

Primary outcome:

Conners Adult ADHD Rating Scale - Short Version (CAARS)

Behavior Rating Inventory of Executive Function - Adult (BRIEF-A)

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

Minimum age: 18 Years. Maximum age: 28 Years. Gender(s): Both.

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

Locations and Contacts

Department of Education and Human Services, Lehigh University, Bethlehem, Pennsylvania 18015, United States

Department of Psychology, University of Rhode Island, Kingston, Rhode Island 02881, United States

Additional Information

Starting date: September 2009
Last updated: April 7, 2014

Page last updated: August 23, 2015

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