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NCT01324024 · ClinicalTrials.gov registry record · Phase 4

Attention & Memory Impairments in Menopausal Women

A Phase 4 study, sponsored by University of Pennsylvania.

Completed
Registry status
Phase 4
Development phase
35
Enrollment target

NCT01324024: Completed Phase 4 study, sponsored by University of Pennsylvania.

NCT01324024 is a Phase 4 study that has completed, run by University of Pennsylvania. The registered enrollment target is 35 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01324024, a Phase 4 study, has completed, sponsored by University of Pennsylvania.

COMPLETED
Registry status
Phase 4
Development phase
35 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether a medication called Vyvanse® (lisdexamfetamine; LDX) has an impact on cognitive functioning, specifically measures of sustained attention, verbal encoding and recall and working memory, in menopausal aged women. LDX is a medication used to treat attention deficit hyperactivity disorder (ADHD). The cognitive difficulties that menopausal women report experiencing are typical of adults who are diagnosed with ADHD. The investigators will assess whether or not LDX is effective in alleviating those cognitive disruptions when compared to a placebo.

Primary Outcome

The BADDS questionnaire is a clinician administered questionnaire that assesses the frequency and severity of five clusters of symptoms reflective of executive dysfunction reported by individuals with ADHD. Participants are asked to rate the frequency and severity of a symptom on a scale from 0 to 3, with 0 meaning that the problem described does not relate to them and 3 indicating that the problem is very true for them and occurs almost daily. The range of severity for the total BADDS score is

Interventions

  • DRUG Placebo
  • DRUG Lisdexamfetamine

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2011-05
Est. Completion 2014-04
Phase Phase 4
University of Pennsylvania

1,423 total trials

What the finished NCT01324024 record still lists

NCT01324024 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).

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

NCT01324024 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01324024 about?

NCT01324024 is a clinical study titled "Attention & Memory Impairments in Menopausal Women". The purpose of this study is to determine whether a medication called Vyvanse® (lisdexamfetamine; LDX) has an impact on cognitive functioning, specifically measures of sustained attention, verbal encoding and recall and working memory, in menopausal aged women. LDX is a medication used to treat atte...

What is the current status of trial NCT01324024?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 35 participants. The study started on 2011-05. Estimated completion is 2014-04.

What interventions are being tested in trial NCT01324024?

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

Who is sponsoring clinical trial NCT01324024?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01324024's enrollment target sits among peer trials

35 1506th of 2000 higher than 481 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 NCT01324024, the US trial registry maintained by the National Library of Medicine. NCT01324024 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.