Depressive Disorder Clinical Trial
Official title:
The Phenomenology and Biophysiology of Progestin-Induced Dysphoria
Often women are prescribed hormone replacement therapy (HRT) during the perimenopause or
menopause.
Hormone replacement therapy includes both estrogen and progesterone. The estrogen component
of HRT helps to relieve the symptoms and has a beneficial effect on the heart and bones, but
estrogen also increases the risk of uterine cancer. The progesterone component of the HRT
(progestin) works to prevent the increased risk of uterine cancer.
There is evidence that some women experience unpleasant mood symptoms (such as irritability,
depressed mood and anxiety) while receiving hormone replacement therapy (HRT) while taking
the progestin / progesterone component of the HRT.
This study is designed to evaluate the ability of progestins to produce negative mood
symptoms in women. Researchers intend on doing this by comparing the effects of
medroxyprogesterone acetate (Provera) and a placebo inactive sugar pill. Patient's moods
will be monitered based on their response to questionnaires answered in the outpatient
clinic and at home.
This research will attempt to answer the following questions:
1. Are progestins associated with changes in mood during hormone replacement therapy?
2. If progestins are associated with mood disturbance, is it because they are blocking the
beneficial effects of estrogen?
There is evidence in the literature that some women experience dysphoric symptoms while receiving hormone replacement therapy (HRT) and that this disturbance in mood is related to the progestin component of the HRT. The bulk of this evidence is anecdotal. While some authors have attempted to examine this putative problem in a more systematic fashion, there are no controlled studies that attempt to identify the mechanism through which the perturbation in mood occurs. Adverse effects of progestins might be mediated directly through the progesterone or androgen receptor. Alternatively, the effects of progestins might be consequent to the antiestrogen effects of progesterone. This latter possibility is in part supported by our observation in previous studies of the beneficial effects of estradiol on mood and the possible precipitation of mood disturbance following acute estrogen withdrawal. Finally, despite the popular lore that progesterone causes mood disturbances, a placebo effect cannot be ruled out, since women taking HRT know when they are receiving the progestin component of the regimen. Our research questions therefore are as follows: 1) Are progestins associated with changes in mood during HRT, and 2) If progestins are associated with mood disturbance, is it because they are blocking the beneficial effects of estrogen? ;
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