Phase 4
Completed N=35
Attention & Memory Impairments in Menopausal Women
Symptomatic Menopause · Cognitive Impairments
Source: ClinicalTrials.gov NCT01324024 ↗
Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Brown Attention Deficit Disorder Scale (BADDS) — 35.7; 21.2; 29.8 units on a scale
◆ Published Evidence
Established
87citations · ~8 / year
New onset executive function difficulties at menopause: a possible role for lisdexamfetamine.
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.
Linked Publications
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New onset executive function difficulties at menopause: a possible role for lisdexamfetamine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brown Attention Deficit Disorder Scale (BADDS) |
35.7; 21.2; 29.8 | — |
| SECONDARY Penn Continuous Performance Test |
53.29; 56.37; 56.21 | — |
| SECONDARY NYU Paragraph Recall Task |
7.09; 7.48; 7.00; 6.38; 7.45; 6.75 | — |
Eligibility Criteria
Inclusion Criteria
Women ages 45 to 60 will be eligible for this study if they:
- Are within 5 years of their last menstrual period;
- Are able to give written informed consent;
- Must have clear urine toxicology screen upon recruitment;
- Are fluent in written and spoken English;
- Must have negative urine pregnancy test if still menstruating.
Exclusion Criteria
- History of seizures;
- History of cardiac disease including known cardiac defect or conduction abnormality;
- Abnormal electrocardiogram during screening;
- Use of estrogen therapy within previous 6 months;
- Current pregnancy or planning to become pregnant.
- Presence of a contraindication to treatment with stimulant medication; this would include the presence of hypertension, coronary disease, atrial fibrillation, and arrhythmia.
Data sourced from ClinicalTrials.gov (NCT01324024) and the linked publication. 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.