Clinical trial NCT01324024: Attention & Memory Impairments in Menopausal Women
Official title: Attention & Memory Impairments in Menopausal Women: A Possible Role for Vyvanse?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Symptomatic Menopause
Cognitive Impairments
Keywords: Menopause
Aging
Memory
Women
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Shire
First posted: 2011-03-28
Enrollment: 35
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Brown Attention Deficit Disorder Scale (BADDS)
timeFrame: Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)
Secondary outcomes:
measure: Penn Continuous Performance Test
timeFrame: Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)
measure: NYU Paragraph Recall Task
timeFrame: Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Center for Women's Behavioral Wellness
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Cynthia N Epperson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Epperson CN, Shanmugan S, Kim DR, Mathews S, Czarkowski KA, Bradley J, Appleby DH, Iannelli C, Sammel MD, Brown TE. New onset executive function difficulties at menopause: a possible role for lisdexamfetamine. Psychopharmacology (Berl). 2015 Aug;232(16):3091-100. doi: 10.1007/s00213-015-3953-7. Epub 2015 Jun 11.