Attention & Memory Impairments in Menopausal Women
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ClinicalTrials.gov Identifier: NCT01324024 |
Recruitment Status :
Completed
First Posted : March 28, 2011
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
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Tracking Information | ||||
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First Submitted Date ICMJE | March 24, 2011 | |||
First Posted Date ICMJE | March 28, 2011 | |||
Results First Submitted Date ICMJE | May 11, 2016 | |||
Results First Posted Date ICMJE | June 28, 2017 | |||
Last Update Posted Date | June 28, 2017 | |||
Study Start Date ICMJE | May 2011 | |||
Actual Primary Completion Date | April 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Brown Attention Deficit Disorder Scale (BADDS) [ Time Frame: Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks) ] The BADDS questionnaire is a clinician administered questionnaire that assesses the frequency and severity of five clusters of symptoms reflective of executive dysfunction reported by individuals with ADHD. Participants are asked to rate the frequency and severity of a symptom on a scale from 0 to 3, with 0 meaning that the problem described does not relate to them and 3 indicating that the problem is very true for them and occurs almost daily. The range of severity for the total BADDS score is 0 to 120, with scores of 55 and above being consistent with full-syndrome ADHD.
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Original Primary Outcome Measures ICMJE |
Brown Attention Deficit Disorder Scale [ Time Frame: 10 weeks ] 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.).
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Cognitive Tasks [ Time Frame: 10 weeks ] 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.
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Attention & Memory Impairments in Menopausal Women | |||
Official Title ICMJE | Attention & Memory Impairments in Menopausal Women: A Possible Role for Vyvanse? | |||
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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
35 | |||
Original Estimated Enrollment ICMJE |
34 | |||
Actual Study Completion Date ICMJE | April 2014 | |||
Actual Primary Completion Date | April 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: Women ages 45 to 60 will be eligible for this study if they:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 45 Years to 60 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01324024 | |||
Other Study ID Numbers ICMJE | 812470 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Responsible Party | University of Pennsylvania | |||
Study Sponsor ICMJE | University of Pennsylvania | |||
Collaborators ICMJE | Shire | |||
Investigators ICMJE |
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PRS Account | University of Pennsylvania | |||
Verification Date | May 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |