Effects of LDX on Functioning of College Students With ADHD

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-12-31

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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Attention-deficit/Hyperactivity Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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lisdexamfetamine dimesylate

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

Group Type EXPERIMENTAL

lisdexamfetamine dimesylate

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Interventions

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lisdexamfetamine dimesylate

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

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Vyvanse LDX

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No