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

This study is currently Recruiting

February 2011 By University of Pennsylvania

First Recieved on March 24, 2011

Last Updated on March 25, 2011

Sponsor: University of Pennsylvania
Collaborators: Shire Pharmaceutical Development
Information provided by: University of Pennsylvania
Identifier: NCT01324024

Purpose

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.

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

Eligibility

Ages Eligible for Study:45 Years
Genders Eligible for Study:Female
Accepts Healthy Volunteers:Accepts Healthy Volunteers
Criteria

Inclusion Criteria: Women ages 45 to 57 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.

Investigators

  • Investigator: C. Neill Epperson, MD - Principal Investigator - University of Pennsylvania

Locations

  • Penn Center for Women's Behavioral Wellness

    Philadelphia, Pennsylvania 19104 United States

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