Perimenopausal Effects of Estradiol on Reward Responsiveness

Completed · Phase 4

Conditions studied: Perimenopausal Depression

In brief

Using neuroimaging, the investigator will study the effects of estrogen on mood and brain function in perimenopausal women either with or without depression.

Key facts

Study ID

NCT02255175

Run by

University of North Carolina, Chapel Hill

People needed

64

Starts

2015-10-01

Expected to finish

2018-10-17

Last updated by the study team

2019-11-12

Who can join

Age: 44 and older, up to 55. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Perimenopause Status: We will employ the Stages of Reproductive Aging Workshop (STRAW) criteria70 to confirm perimenopausal status. The stages are primarily based on the characteristics of the menstrual cycle and secondarily on follicle stimulating hormone (FSH) levels. The anchor for the staging system is the final menstrual period (FMP). We will enroll women who have ≥ 2 skipped cycles and an interval of amenorrhea ≥ 60 days, consistent with the late menopause transition (stage -1), and who demonstrate an FSH level > 25 IU/mL. Because extremes of body weight (BMI < 18 or > 30 kg/m2) or a history of chronic menstrual cycle irregularity can contribute to inaccurate reproductive staging, these will serve as additional exclusion criteria;
• MDD Group Eligibility Criterion: current diagnosis of MDD with an onset associated with menstrual cycle irregularity, and no history of psychiatric illness during the 2 years before the onset of the current depressive episode as determined by the Structured Clinical Interview for DSM-IV-TR (Diagnostic and Statistical Manual-4-Text Revision) for Axis I Disorders (SCID);
• Control Group Eligibility Criterion: absence of any past or present psychiatric disorder as assessed by the SCID.

You may not qualify if…

• Patients will not be permitted to enter this protocol if they have any of the following:
• current medication use (i.e., psychotropics, anti-hypertensives, statins, hormonal preparations, or frequent use of anti-inflammatory agents (> 10 times/month)). Women will be allowed to enroll who take medications without known mood effects (e.g. stable thyroid hormone replacement and occasional (< 5 times/month) use of Ambien)*;
• pregnant, breastfeeding or trying to conceive;
• FMP more than 12 months prior to enrollment;
• history of undiagnosed vaginal bleeding;
• undiagnosed enlargement of the ovaries;
• polycystic ovary syndrome;
• history of breast or ovarian cancer;
• first degree relative with ovarian cancer;
• first degree relative with premenopausal onset or bilateral breast cancer;
• 2+ first degree relatives with breast cancer (regardless of onset);
• 3+ relatives with postmenopausal breast cancer;
• abnormal finding in a provider breast exam and/or mammogram;
• known carrier of BRCA1 or 2 mutation;
• endometriosis;
• blood clots in the legs or lungs;
• porphyria;
• diabetes mellitus;
• malignant melanoma;
• Hodgkin's disease;
• recurrent migraine headaches that are preceded by aura;
• gallbladder or pancreatic disease**;
• heart or kidney disease**;
• liver disease;
• cerebrovascular disease (stroke);

Where it is running

• University of North Carolina — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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