Placebo Controlled Study of Atomoxetine in the Treatment of Mild to Moderate Cognitive Difficulties in Menopausal Women

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: Female

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 addition, we seek to determine, using the Brown Attention Deficit Disorder Scale (BADDS), whether and to what degree peri- and early post-menopausal women experience cognitive disturbances which overlap with the impairments of executive function characteristic of adults with attention deficit disorder (ADHD).

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: Eli Lilly and Company
• Treatments: Atomoxetine Hydrochloride

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.