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Arch Womens Ment Health. 2019 Aug 1. doi: 10.1007/s00737-019-00991-3. [Epub ahead of print]

Transdermal estradiol for postpartum depression: results from a pilot randomized, double-blind, placebo-controlled study.

Author information

1
Harvard Medical School, Boston, MA, USA.
2
Section on Behavioral Endocrinology, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.
3
Biostatistics and Epidemiology, National Institutes of Health Clinical Center, Bethesda, MD, USA.
4
National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, USA.
5
Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
6
Section on Behavioral Endocrinology, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. PeterSchmidt@mail.nih.gov.

Abstract

Postpartum depression (PPD) is a common complication following delivery, though evidence-based treatment options are limited. This study explores the feasibility and efficacy of outpatient PPD treatment with transdermal estradiol (TE). In a pilot, double-blind, placebo-controlled trial, women with PPD were randomized to receive transdermal 17β-estradiol (100 mcg/day) or placebo patch. Over 6 weeks, women completed weekly ratings on the Beck Depression Inventory (BDI), Edinburgh Postnatal Depression Scale (EPDS), and Hamilton Depression Scale (HAM-D). Primary outcome measures were treatment response (> 50% decrease from baseline BDI) and remission (BDI < 10) at 6 weeks, and secondary outcome measures included severity on all scales at weeks 3 and 6. Of 12 recruited women, 6 received TE and 6 received placebo. By week 6, 5 women receiving TE responded to treatment and 4 showed symptom remission, compared to 2 responders and 1 remitter in the placebo group. This difference was not significant (p = 0.24). In a mixed-model of BDI ratings, TE was associated with a 9.2 point decrease at 3 weeks (95%CI - 19.5 to + 1.0, p = 0.074) and a 10.5 point decrease at 6 weeks (95%CI - 21.0-0.0, p = 0.049) compared to placebo, though these differences did not survive multiple comparisons correction. Analogous effects were found for HAM-D but not EPDS scores. Interestingly, no significant difference in plasma estradiol levels existed between groups. We were unable to demonstrate a significant therapeutic benefit of TE compared with placebo in PPD. Although limited by under-recruitment and loss to follow-up, our results suggest TE is a feasible option for outpatient PPD management, with preliminary evidence (based on secondary outcomes) for efficacy. Therapeutic effects may be seen as early as 3 weeks and may not directly depend on peripheral measures of estradiol.

KEYWORDS:

Postpartum depression; Randomized controlled trial; Transdermal estradiol

PMID:
31372757
DOI:
10.1007/s00737-019-00991-3

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