Status:
COMPLETED
Placebo Controlled Study of Atomoxetine in the Treatment of Mild to Moderate Cognitive Difficulties in Menopausal Women
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Menopause
Cognitive Disturbances
Eligibility:
FEMALE
45-60 years
Phase:
NA
Brief Summary
The purpose of this study is to examine the efficacy of atomoxetine (ATX) treatment for the mild to moderate cognitive disturbances frequently experienced by women during the menopause transition. In ...
Detailed Description
Decline in cognitive function, and in particular memory, is a frequent complaint for which menopausal women seek clinical intervention. While there is a wealth of preclinical evidence demonstrating th...
Eligibility Criteria
Inclusion
- Menopausal subjects between the ages of 45 and 60 years;
- Physically healthy with no major medical illnesses;
- No history within the past 5 years of a DSM-IV psychiatric or substance abuse diagnosis by structured diagnostic interview (SCID);
- Subjects will be determined to be either peri or post-menopausal;
- Subjects must be within 5 years of their last menstrual period;
- Subjective report of cognitive disturbances of at least mild to moderate severity;
- All subjects must be of at least average intelligence as determined using the Wechsler Abbreviated Scale of Intelligence (WASI).
Exclusion
- Clinical evidence of dementia and/or signs of dementia on the Mini-Mental Status Exam (MMSE score of \<22);
- History of familial dementia;
- Use of any psychotropic medication within the previous 6 months;
- Use of any estrogen replacement therapy within the previous 6 months;
- Current pregnancy;
- Signs of an unstable medical or neurological disorder.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00611533
Start Date
May 1 2004
End Date
April 1 2008
Last Update
April 17 2017
Active Locations (1)
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1
Yale University School of Medicine
New Haven, Connecticut, United States, 06511