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Attention & Memory Impairments in Menopausal Women

Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Symptomatic Menopause; Cognitive Impairments

Intervention: Lisdexamfetamine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Pennsylvania

Official(s) and/or principal investigator(s):
Cynthia N Epperson, MD, Principal Investigator, Affiliation: University of Pennsylvania

Summary

The purpose of this study is to determine whether a medication called VyvanseŽ (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.

Clinical Details

Official title: Attention & Memory Impairments in Menopausal Women: A Possible Role for Vyvanse?

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Brown Attention Deficit Disorder Scale

Secondary outcome: Cognitive Tasks

Eligibility

Minimum age: 45 Years. Maximum age: 60 Years. Gender(s): Female.

Criteria:

Inclusion Criteria: Women ages 45 to 60 will be eligible for this study if they:

- Are within 5 years of their last menstrual period;

- Are able to give written informed consent;

- Must have clear urine toxicology screen upon recruitment;

- Are fluent in written and spoken English;

- Must have negative urine pregnancy test if still menstruating.

Exclusion Criteria:

- History of seizures;

- History of cardiac disease including known cardiac defect or conduction abnormality;

- Abnormal electrocardiogram during screening;

- Use of estrogen therapy within previous 6 months;

- Current pregnancy or planning to become pregnant.

- Presence of a contraindication to treatment with stimulant medication; this would

include the presence of hypertension, coronary disease, atrial fibrillation, and arrhythmia.

Locations and Contacts

Penn Center for Women's Behavioral Wellness, Philadelphia, Pennsylvania 19104, United States
Additional Information

Click here for more information about our center.

Related publications:

Epperson CN, Pittman B, Czarkowski KA, Bradley J, Quinlan DM, Brown TE. Impact of atomoxetine on subjective attention and memory difficulties in perimenopausal and postmenopausal women. Menopause. 2011 May;18(5):542-8. doi: 10.1097/gme.0b013e3181fcafd6.

Starting date: May 2011
Last updated: May 2, 2014

Page last updated: August 23, 2015

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