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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00059228 |
This study evaluates the efficacy of estrogen treatment in women with postpartum depression (PPD).
PPD causes significant distress to a large number of women; the demand for effective therapies to treat PPD is considerable. Estradiol therapy has a prophylactic effect in women at high risk for developing PPD. The prevention of a decline in estradiol levels may prevent the onset of PPD. Studies also suggest that estradiol has antidepressant effects in women and may provide a safe and effective alternative to traditional antidepressants in women with PPD.
Participants will be screened with a medical history, physical examination, blood and urine tests, psychological tests, genetic studies, and self-rating scales and questionnaires. Upon study entry, women will be randomly assigned to wear skin patches containing either estradiol or placebo (a patch with no active ingredient) for 6 weeks. Women who receive estradiol and do not menstruate during the last week of the study will receive progesterone for 7 days to initiate menstruation. Women who receive placebo and do not menstruate during the last week of the study will continue to receive placebo at the end of the study. Every week, participants will have blood taken and will be asked to complete symptom self-rating scales. A urine sample and blood samples will be collected at different time points through out of the study. Participants who receive placebo and those whose symptoms do not improve with estradiol therapy will be offered treatment with standard antidepressant medications for 8 weeks at the end of the study.
Condition | Intervention | Phase |
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Postpartum Depression Depression |
Drug: 17 beta-estradiol |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | The Efficacy of 17Beta-Estradiol in Postpartum-Related Depressive Illness |
Estimated Enrollment: | 44 |
Study Start Date: | April 2003 |
Arms | Assigned Interventions |
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1: Experimental
Experimental
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Drug: 17 beta-estradiol
Alora 100 microgram per day by skin patch for 6 weeks.
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2: Placebo Comparator
Placebo comparator
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Drug: 17 beta-estradiol
Alora 100 microgram per day by skin patch for 6 weeks.
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Postpartum-related mood disorders cause significant distress to a potentially large number of women. The demand for effective therapies for treating these mood disorders is considerable, as is the need to define clinical or biologic markers that may predict successful response of these mood disturbances to estradiol. Despite the prevalence of postpartum depressions, only one double-blind, placebo-controlled trial of a single psychotropic agent has been performed in this condition. Similarly, despite evidence of estradiol's therapeutic efficacy in trials that were both open (monotherapy)
(1) and controlled (combined with traditional antidepressant agents (2), the potential of estradiol to be an effective alternative to traditional psychotropics in postpartum depression has not been examined under controlled conditions.
Postpartum depressions occur by definition after delivery when women are relatively hypogonadal. Indeed, plasma estradiol and progesterone levels are low and comparable to those seen during the peri and postmenopause. However, there is no evidence that postpartum depression represents a simple hormone deficiency, and women with postpartum depression are not distinguished from women without postpartum depression on the basis of any abnormality of basal reproductive hormones. Nonetheless, a role for declining estradiol secretion has been suggested by the following observations: 1) estradiol therapy has been reported to have a prophylactic effect in women at high risk for developing postpartum depression (3), suggesting that the prevention of a decline in estradiol levels (threshold or rate of decline) may prevent the onset of postpartum depression in some women; and (2) declining ovarian steroids trigger the onset of mood disturbances in women with but not women without a history of postpartum depression during a scaled down model of pregnancy in the puerperium (4). Thus, as with depressions occurring during the perimenopause, when ovarian hormone secretion is also declining, postpartum depression may also be responsive to estradiol therapy. In fact, open trials of estradiol therapy in postpartum depression (1) as well as a trial of estradiol in combination with traditional antidepressants (2) have suggested that estradiol does have antidepressant-like effects that are observed within a three week period in women with postpartum onset major depression. Thus, estradiol treatment may not only provide a safe and effective alternative to traditional antidepressants in women with postpartum depression, but it may also suggest the relevant hormonal trigger for the development of this condition.
In this protocol we wish to investigate the effects of estradiol on mood in women with moderately severe postpartum depression under placebo controlled conditions. This protocol will address the following question: 1) Does estradiol improve mood in postpartum depressed women?
Ages Eligible for Study: | 20 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Subjects for this study will meet the following criteria:
5.) No prior hormonal therapy for the treatment of postpartum-related mood or physical symptoms within the last six months;
6) No history of psychiatric illness during the two years prior to the reported onset of the current episode of depression;
7) In good medical health, and not taking any medication or dietary and herbal supplements on a regular basis (with the exception of multivitamins or calcium supplements).
EXCLUSION CRITERIA:
The following conditions will constitute contraindications to treatment and will preclude a subject's participation in this protocol:
1) severe major depression with any of the following:
2) current treatment with antidepressant medications
3) history of psychiatric illness during the two years before the reported onset of the current episode of depression or a history of either mania (DSM-IV criteria) or postpartum psychosis at any time in the past.
4) history of ischemic cardiac disease, pulmonary embolism, retinal thrombosis, or thrombophlebitis; any subject with risk factors for thrombo-embolic phenomena including cigarette smokers (greater than 10 cigarettes per day), varicose veins, patients with prolonged periods of immobilization (including prolonged travel), and active heart disease.
5) renal disease, asthma
6) hepatic dysfunction
7) women with a history of carcinoma of the breast, or women with a family history of the following: premenopausal breast cancer or bilateral breast cancer in a first degree relative; multiple family members (greater than three relatives) with postmenopausal breast cancer
8) women with a history of uterine cancer, endometriosis, ill-defined pelvic lesions, particularly undiagnosed ovarian enlargement, undiagnosed vaginal bleeding
9) patients with a known hypersensitivity of estradiol, Alora, or medroxyprogesterone acetate
10) pregnant women
11) porphyria
12) diabetes mellitus
13) cholecystitis or pancreatitis
14) history of cerebrovascular disease (stroke), epilepsy, hypertension, hypercalcemia
15) recurrent migraine headaches
16) malignant melanoma
17) history of familial hyperlipoproteinemia
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Responsible Party: | National Institutes of Health ( Peter J. Schmidt, M.D./National Institute of Mental Health ) |
Study ID Numbers: | 030161, 03-M-0161 |
Study First Received: | April 22, 2003 |
Last Updated: | March 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00059228 History of Changes |
Health Authority: | United States: Federal Government |
Pregnancy Gonadal Steroids Antidepressants Puerperium Depression |
Postpartum Estradiol Estrogen Response Element Postpartum Depression |
Estrogens Depression Pregnancy Complications Contraceptive Agents Benzoates Hormone Antagonists Estradiol valerate Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Estradiol 17 beta-cypionate Depressive Disorder |
Hormones Estradiol Behavioral Symptoms Depression, Postpartum Puerperal Disorders Mental Disorders Estradiol 3-benzoate Mood Disorders Polyestradiol phosphate Antidepressive Agents |
Estrogens Depression Pregnancy Complications Contraceptive Agents Physiological Effects of Drugs Estradiol valerate Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Estradiol 17 beta-cypionate Depressive Disorder |
Hormones Pharmacologic Actions Estradiol Behavioral Symptoms Depression, Postpartum Puerperal Disorders Mental Disorders Therapeutic Uses Estradiol 3-benzoate Mood Disorders Polyestradiol phosphate |