Attention & Memory Impairments in Menopausal Women

University of Pennsylvania

Status and phase: Completed; Phase 4

Conditions: Symptomatic Menopause; Cognitive Impairments

Treatments: Drug: Lisdexamfetamine; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01324024

812470

Details and patient eligibility

About

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.

Full description

Midlife decline in cognitive function, particularly attention and working memory, is a frequent complaint for which menopausal women seek clinical intervention. Many of the cognitive complaints detected in menopausal women including, short-term memory, organization of tasks, sustaining focus and concentration, and regulating emotions, overlap with symptoms frequently reported by adults with ADHD. These impairments are reported by many women who have no previous history of ADHD, and appear to be linked to reduced estrogen levels occurring in menopause.

This is a double-blind, placebo-controlled, cross-over study testing whether LDX, a stimulant medication, would be effective in alleviating midlife onset impairments of attention and working memory among menopausal women. There will be 3 days in which subjects will undergo a brief cognitive testing assessment; the first testing period will occur at baseline prior to beginning LDX or placebo treatment (PT) in trial A; the second testing period will occur following 4 weeks of double blind LDX or PT; and the final testing period will take place after another 4 weeks of double blind LDX or PT in Trial B. Each cognitive test period will involve 2 separate cognitive testing batteries that will take approximately 120 minutes total to complete.

Enrollment: 35 patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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35 participants in 2 patient groups

Lisdexamfetamine, then placebo

Experimental group

Description:

Participants first received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks followed by a 2-week washout, then they received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.

Treatment:

Drug: Placebo

Drug: Lisdexamfetamine

Placebo, then Lisdexamfetamine

Experimental group

Description:

Participants first received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks followed by a 2-week washout, then they received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks.

Treatment:

Drug: Placebo

Drug: Lisdexamfetamine