Clinical Trial of Estrogen for Postpartum Depression

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Postpartum Depression, Depression

In brief

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.

Key facts

Study ID

NCT00059228

Run by

National Institute of Mental Health (NIMH)

People needed

12

Starts

2003-04-17

Expected to finish

2016-11-15

Last updated by the study team

2018-06-13

Who can join

Age: 20 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• The following conditions will constitute contraindications to treatment and will preclude a subject s participation in this protocol:
• severe major depression with any of the following:
• positive (threshold) response to SCID major depression section item # 9, suicidal ideation;
• anyone requiring immediate treatment after clinical assessment;
• severity ratings greater than moderate on the SCID IV interview (including postpartum psychosis);
• current treatment with antidepressant medications
• 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.
• 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.
• renal disease, asthma
• hepatic dysfunction
• 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
• women with a history of uterine cancer, endometriosis, ill-defined pelvic lesions, particularly undiagnosed ovarian enlargement, undiagnosed vaginal bleeding
• patients with a known hypersensitivity to estradiol, transdermal skin patches, or medroxyprogesterone acetate
• pregnant women
• porphyria
• diabetes mellitus
• cholecystitis or pancreatitis
• history of cerebrovascular disease (stroke), epilepsy, hypertension, hypercalcemia
• recurrent migraine headaches
• malignant melanoma
• history of familial hyperlipoproteinemia
• prior hormonal therapy for the treatment of postpartum-related mood or physical symptoms within the last six months
• history of psychiatric illness during the two years prior to the reported onset of the current episode of depression

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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