Effects of LDX on Functioning of College Students With ADHD

University of Rhode Island

Status and phase: Completed; Phase 4

Conditions: Attention-deficit/Hyperactivity Disorder

Treatments: Drug: lisdexamfetamine dimesylate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01342445

Shire-80000311112

Details and patient eligibility

About

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).

Full 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).

Enrollment: 50 patients

Sex: All

Ages: 18 to 28 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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50 participants in 1 patient group

lisdexamfetamine dimesylate

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: lisdexamfetamine dimesylate