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NCT01342445 · ClinicalTrials.gov registry record · Phase 4

Effects of LDX on Functioning of College Students With ADHD

A Phase 4 study, sponsored by University of Rhode Island.

Completed
Registry status
Phase 4
Development phase
50
Enrollment target

NCT01342445: Completed Phase 4 study, sponsored by University of Rhode Island.

NCT01342445 is a Phase 4 study that has completed, run by University of Rhode Island. The registered enrollment target is 50 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01342445, a Phase 4 study, has completed, sponsored by University of Rhode Island.

COMPLETED
Registry status
Phase 4
Development phase
50 participants
Enrollment target

Study 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).

Primary Outcome

CAARS ADHD Index, adult self-report measure of ADHD symptoms. T-scores (mean = 50; standard deviation = 10) for all subscales on the short version were used as dependent measures with higher scores representing greater ADHD symptomatology (and ultimately a worse outcome in this study).

Interventions

  • DRUG Placebo
  • DRUG lisdexamfetamine dimesylate

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2009-09
Est. Completion 2010-12
Phase Phase 4
University of Rhode Island

29 total trials

What the finished NCT01342445 record still lists

NCT01342445 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01342445 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01342445 about?

NCT01342445 is a clinical study titled "Effects of LDX on Functioning of College Students With ADHD". 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 ...

What is the current status of trial NCT01342445?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2009-09. Estimated completion is 2010-12.

What interventions are being tested in trial NCT01342445?

The interventions under investigation include: Placebo (DRUG), lisdexamfetamine dimesylate (DRUG).

Who is sponsoring clinical trial NCT01342445?

This trial is sponsored by University of Rhode Island, which has 29 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01342445's enrollment target sits among peer trials

50 1255th of 2000 higher than 678 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01342445, the US trial registry maintained by the National Library of Medicine. NCT01342445 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.