Attention & Memory Impairments in Menopausal Women

Cognitive Impairments Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01324024
• Other study ID #: 812470
• Status: Completed
• Phase: Phase 4
• First received: March 24, 2011
• Last updated: May 2, 2014
• Start date: May 2011
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairments
• Symptomatic Menopause

Intervention

Drug:
• Lisdexamfetamine
The purpose of this study is to assess whether or not lisdexamfetamine is effective in alleviating cognitive disruptions when compared to a placebo.

Locations

Country	Name	City	State
United States	Penn Center for Women's Behavioral Wellness	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Shire

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brown Attention Deficit Disorder Scale	The primary objective of this study is to reduce subjective symptoms of executive function impairment in peri and early postmenopausal women who are concerned about their "memory" and/or "cognition." Subjective assessment of executive functioning such as a sustained attention, focus, organization, working memory and motivation for work/activities will be assessed with our primary outcome variable, the Brown Attention Deficit Disorder Scale (BADDS; Brown, 1996, Harcourt Brace & Co.).	10 weeks	No
Secondary	Cognitive Tasks	The secondary objective of this study is to determine whether LDX improves performance on objective measures of sustained attention, verbal recall and working memory. This will be measured using a battery of cognitive tasks aimed at assessing sustained attention, verbal encoding and recall, and verbal working memory. These tasks include the STROOP test; NYU Paragraph Recall Test; Spatial Span Forward and Spatial Span Backward from the Wechsler Memory Scale; 3-Back Task; and Verbal Paired Associates II.	10 weeks	No

External Links

•   Click here for more information about our center.