At a glance
ClinicalIndex Comparison Record- ✓Age 48-60 years at enrollment
- ✓Within 10 years 11 months of last menstrual period
- ✓FSH level >30 IU/ml
- ✓No major depressive disorder, generalized anxiety disorder, or panic disorder in last 3 years (or resolved if prior)
- ✕Smoking >10 cigarettes/day
- ✕History of clinical cardiovascular disease (myocardial infarction, angina, congestive heart failure)
- ✕History of thromboembolic disease (deep vein thrombosis or pulmonary embolus)
- ✕History of untreated gallbladder disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Interaction of Estrogen and Serotonin in Modulating Brain Activation in Menopause
In Brief
A clinical study evaluating estrogen patch, Amino acids, and 2 other interventions for Menopause. Completed, enrolled 47 participants across 1 site.
Detailed Summary
The aim of this study is to examine the effects of estrogen and serotonin on cognition, emotional processing, and brain activation. The investigators will study the effects of acute tryptophan (TRP) depletion on cognition and mood in healthy menopausal women before and after estrogen replacement treatment (ERT). Using functional magnetic resonance imaging (fMRI), the investigators will identify differences in brain activation during memory tasks with and without TRP depletion and before and after estrogen therapy in order to determine which brain regions and cognitive functions are affected by each manipulation.
Study Details
Timeline
Interventions
150 subjects will be enrolled in a double blind placebo controlled study where they will be randomized to receive either treatment with 17β-estradiol (Vivelle Dot® 0.10 - 0.15 mg/day) or a look-alike placebo patch for a total of approximately 8 weeks. There will be four fMRI test sequences: two test sequences one week apart prior to estrogen treatment (ET) or placebo treatment (PT), and two sequences one week apart following approximately 6-weeks of double-blind ET or PT. During each test day, all subjects will have their blood drawn at specific time intervals and undergo a battery of cognitive testing.While on the ET or PT treatment, all subjects will be instructed to change the patch every 3.5 days.
31.5 mg of amino acids or 31.5 mg of lactose will be administered to subjects on each of their 4 test days. On 2 of the test days subjects will receive the active pills (amino acids) and on the other 2 test days subjects will receive the placebo pills (lactose).
placebo
There are 4 test days in this study. Each test day will involve the ingestion of 70 capsules. During one of each pair of tests, the 70 capsules will contain 31.5 g of lactose (sham depletion), while during the other test they will contain a total of 31.5 g of amino acids.