CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 18 enrolled
Drug / intervention
Lisdexamfetamine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01977625
NCT01977625Phase 4Completed
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Utilizing fMRI to Determine the Effects of Vyvanse® on Memory, Attention, and Brain Activity in Menopausal Women

University of Pennsylvania·interventional·Posted Nov 6, 2013·Updated Jul 27, 2018

In Brief

A Phase 4 clinical trial evaluating Lisdexamfetamine and Placebo for Menopause and 2 related conditions. Completed, enrolled 18 participants across 1 site.

Detailed Summary

This study seeks to assess the effects of lisdexamfetamine (trademark name: Vyvanse; LDX) on executive function and prefrontal cortex activation in menopausal women ages 45-57, who report subjective cognitive difficulties. This protocol will recruit women from Dr. Epperson's ongoing study, Protocol #812470, to examine the impact of LDX on brain activation during performance of cognitive tasks specifically probing prefrontal cortex function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMenopause, Brain Activity, Cognition
CountriesUnited States
CollaboratorsShire

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 6, 2013
Enrollment StartDec 1, 2011
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 12.7 years ago

Interventions

Lisdexamfetaminedrug

The overall objective of this study is to assess the effects of LDX on brain activation patterns during tasks of sustained attention and working memory in menopausal women.

Placeboother

To assess the effects of a placebo pill on brain activation patterns during tasks of sustained attention and working memory in menopausal women.