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LDX and Functional Magnetic Resonance Imaging (fMRI in Menopausal Women

NCT01977625 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-07-27

Study results available
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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.

Conditions

Interventions

DRUG

Lisdexamfetamine

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.

OTHER

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Cynthia Neill Epperson, M.D. · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01977625 on ClinicalTrials.gov