Attention & Memory Impairments in Menopausal Women
This study is currently recruiting participants.
Verified February 2013 by University of Pennsylvania
Sponsor:
University of Pennsylvania
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 24, 2011 | ||||||||
| Last Updated Date | February 11, 2013 | ||||||||
| Start Date ICMJE | March 2011 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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.). |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01324024 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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® |
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| Study Arm (s) |
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| Publications * | 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 Feb 2; [Epub ahead of print] | ||||||||
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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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 34 | ||||||||
| Estimated Completion Date | June 2013 | ||||||||
| Estimated Primary Completion Date | June 2013 (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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| Gender | Female | ||||||||
| Ages | 45 Years to 60 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01324024 | ||||||||
| Other Study ID Numbers ICMJE | 812470 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | C. Neill Epperson, University of Pennsylvania | ||||||||
| Study Sponsor ICMJE | University of Pennsylvania | ||||||||
| Collaborators ICMJE | Shire Development LLC | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Pennsylvania | ||||||||
| Verification Date | February 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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