Attention & Memory Impairments in Menopausal Women

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: Shire
• Treatments: Lisdexamfetamine Dimesylate

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.