N/A Completed N=16 Randomized Triple-blind Treatment

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

Menopause · Cognitive Disturbances

Source: ClinicalTrials.gov NCT00611533 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2017

Primary outcomePrimary: Brown Attention Deficit Disorder Scale — 60.7; 55.6; 56.3; 58.8 T score

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Brown Attention Deficit Disorder Scale	60.7; 55.6; 56.3; 58.8; 52.1; 56.4	—
PRIMARY BADDS Total Score	38.6; 25.5; 30.1	—
SECONDARY Blood Pressure	118.8; 116.7; 120.3; 74; 69.8; 70.7	—
SECONDARY Heart Rate	63; 68.8; 66.3	—
SECONDARY Weight	160.1; 158.1; 159.8	—

Eligibility 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.

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Data sourced from ClinicalTrials.gov (NCT00611533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.