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?
Status | Completed |
Enrollment | 50 |
Est. completion date | March 2003 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
INCLUSION CRITERIA The subjects in this study will be women who meet the following criteria: 1. history of mood and/or behavioral symptoms associated with hormone replacement therapy; 2. age 40 to 65; 3. in good medical health. EXCLUSION CRITERIA Any subject with significant physical, EKG, mammogram or laboratory abnormalities will not participate in this protocol. Additionally prior to participation all subjects will be examined for any contradictions to estrogen therapy (as determined by a pelvic exam and mammogram) within the past year by a gynecologist of their choice. In those patients who are unable to independently arrange this exam, we have arranged for a consultant gynecologist to be available through our collaboration with NICHD. |
N/A
Country | Name | City | State |
---|---|---|---|
United States | National Institute of Mental Health (NIMH) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Mental Health (NIMH) |
United States,
Magos AL, Brewster E, Singh R, O'Dowd T, Brincat M, Studd JW. The effects of norethisterone in postmenopausal women on oestrogen replacement therapy: a model for the premenstrual syndrome. Br J Obstet Gynaecol. 1986 Dec;93(12):1290-6. — View Citation
Smith RN, Holland EF, Studd JW. The symptomatology of progestogen intolerance. Maturitas. 1994 Feb;18(2):87-91. — View Citation
Wagner KD. Major depression and anxiety disorders associated with Norplant. J Clin Psychiatry. 1996 Apr;57(4):152-7. — View Citation
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