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Attention & Memory Impairments in Menopausal Women

This study is currently recruiting participants.
Verified February 2013 by University of Pennsylvania
Sponsor:
Collaborator:
Shire Development LLC
Information provided by (Responsible Party):
C. Neill Epperson, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01324024
First received: March 24, 2011
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  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.


Condition Intervention Phase
Symptomatic Menopause
Cognitive Impairments
 Drug: Lisdexamfetamine
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Brown Attention Deficit Disorder Scale [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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.).


Secondary Outcome Measures:
  • Cognitive Tasks [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 34
Study Start Date: March 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lisdexamfetamine
Lisdexamfetamine or Vyvanse
 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.
Other Name: Vyvanse®
Placebo Comparator: Sugar Pill
Placebo pill, capsules
 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.
Other Name: Vyvanse®

  Eligibility

Ages Eligible for Study:   45 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01324024

Contacts
Contact: Jeanette Bradley, BA 215-573-8884 jbradl@upenn.edu
Contact: Kathryn Czarkowski, MA 215-573-8882 kczar@upenn.edu

Locations
United States, Pennsylvania
Penn Center for Women's Behavioral Wellness Recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Shire Development LLC
Investigators
Principal Investigator: Cynthia N Epperson, MD University of Pennsylvania
  More Information

Additional Information:
Click here for more information about our center.  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: C. Neill Epperson, Associate Professor of Psychiatry, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01324024     History of Changes
Other Study ID Numbers: 812470
Study First Received: March 24, 2011
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Menopause
Aging
Memory
Women

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dextroamphetamine
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013