Phase 4
N=50
Effects of LDX on Functioning of College Students With ADHD
Attention-deficit/Hyperactivity Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01342445 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Conners Adult ADHD Rating Scale - Short Version (CAARS) — 50.59; 46.86; 47.32; 45.36 T score — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- lisdexamfetamine dimesylate (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Rhode Island
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Conners Adult ADHD Rating Scale - Short Version (CAARS) |
50.59; 46.86; 47.32; 45.36 | <0.001 sig |
| PRIMARY Behavior Rating Inventory of Executive Function - Adult (BRIEF-A) |
65.91; 59.23; 57.64; 54.91 | <.001 sig |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01342445). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.