Effect of Adjunctive Estradiol on Schizophrenia Among Women of Childbearing Age: A Randomized Clinical Trial
Open accessAbstract
Importance: Several lines of evidence suggest that estradiol influences the course of schizophrenia, and a previous randomized controlled trial demonstrated that transdermal estradiol improved symptoms in female patients of childbearing age. However, many initial positive findings in schizophrenia research are not later replicated. Objective: To independently replicate the results of the effect of estradiol on schizophrenia in women of childbearing age. Design, Setting, and Participants: An 8-week randomized, placebo-controlled trial performed in the Republic of Moldova between December 4, 2015, and July 29, 2016, among 200 premenopausal women aged 19 to 46 years with schizophrenia or schizoaffective disorder as defined by the DSM-5. Intervention: Patients were randomized to receive a 200-μg estradiol patch or placebo patch changed twice a week added to their antipsychotic treatment. Main Outcomes and Measures: The primary outcome was the positive subscale of the Positive and Negative Syndrome Scale (PANSS; lower scores indicated fewer symptoms and higher scores indicated more symptoms), analyzed with mixed models for repeated measures on an intention-to-treat basis. Results: A total of 100 women (median age, 38 years; interquartile range, 34-42 years) were randomized to receive an estradiol patch and 100 women (median age, 38 years; interquartile range, 31-41 years) were randomized to receive a placebo patch; the median age at baseline for the entire group of 200 women was 38.0 years (range, 19.5-46.0 years). At baseline, the mean positive PANSS score was 19.6 for both groups combined; at week 8, the mean positive PANSS score was 14.4 in the placebo group and 13.4 in the estradiol group. Compared with placebo, participants receiving add-on estradiol patches had statistically significant improvements in the primary outcome measure, PANSS positive subscale points (-0.94; 95% CI, -1.64 to -0.24; P = .008; effect size = 0.38). Post hoc heterogeneity analyses found that this effect occurred almost entirely in 100 participants older than 38.0 years (46 in placebo group vs 54 in estradiol group; difference, -1.98 points on the PANSS positive subscale; 95% CI, -2.94 to -1.02; P < .001). Younger participants did not benefit from estradiol (difference, 0.08 points on the PANSS positive subscale; 95% CI, -0.91 to 1.07; P = .87). Breast tenderness was more common in the estradiol group (n = 15) than in the placebo group (n = 1) as was weight gain (14 in estradiol group vs 1 in placebo group). Conclusions and Relevance: The results independently replicate the finding that transdermal estradiol is an effective add-on treatment for women of childbearing age with schizophrenia and extend it, finding improvements in negative symptoms and finding that the effect could be specific to those older than 38 years. The results should be viewed in the context of the differences in the natural course of schizophrenia between females and males. Trial Registration: ClinicalTrials.gov identifier: NCT03848234.
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In a recent 8-week, double-blind, randomized, placebo-controlled parallel-group study of 200 women with schizophrenia randomized to a 200 μg estradiol patch or placebo added to antipsychotics, participants receiving estradiol had significant improvement in positive and negative symptoms as well as general psychopathology.
“In a recent 8‐week, double‐blind, randomized, placebo‐controlled parallel‐group study of 200 women with schizophrenia randomized to a 200 μg estradiol patch or placebo added to antipsychotics, participants receiving estradiol had significant improvement in positive and negative symptoms as well as general psychopathology 267 .”
From Mental health care for older adults: recent advances and new directions in clinical practice and research (2022) · cites this paper as [267]
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- Authors
- Weiser, M., Levi, L., Zamora, D., Biegon, A., SanGiovanni, J. P., Davidson, M., Burshtein, S., Gonen, I., Radu, P., Slobozean Pavalache, K., Nastas, I., Hemi, R., Ryan, T., & Davis, J. M.
- Affiliations
- Tel Aviv University (IL)
- Sheba Medical Center (IL)
- University of North Carolina at Chapel Hill (US)
- Stony Brook School (US)
- National Institutes of Health (US)
- University of Nicosia (CY)
- Tangent Alzheimer Care, Breaza, Romania
- Republican Psychiatric Hospital, Chișinău, Moldova
- Nicolae Testemițanu State University of Medicine and Pharmacy (MD)
- University of Illinois Chicago (US)
- Johns Hopkins University (US)
- Corresponding author
- Weiser, Mark
- ORCID
- Venue
- JAMA Psychiatry
- Publisher
- American Medical Association (AMA)
- Published
- 2019-10-01
- Volume
- 76
- Issue
- 10
- Pages
- 1009
- ISSN
- 2168-622X (ISSN-L)
- PMC
- PMC6669788
- OpenAlex
- W2964402256
- Cited by
- 42
- References
- 32
- Citations by year
- 2026: 6 · 2025: 5 · 2024: 6 · 2023: 3 · 2022: 8 · 2021: 6 · 2020: 5 · 2019: 3
- FWCI
- 4.38
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA Psychiatry (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Social Sciences › Arts and Humanities › Philosophy › Mental Health and Psychiatry
- Keywords
- estradiol, schizophrenia, women of reproductive age, adjunctive therapy, antipsychotic drugs, positive symptoms, schizoaffective disorder, premenopausal women, PANSS, age differences in treatment response
- MeSH terms
- Adult, Age Factors, Double-Blind Method, Drug Therapy, Combination, Estradiol, Estrogens, Female, Humans, Middle Aged, Schizophrenia, Antipsychotic Agents, Outcome Assessment, Health Care, Young Adult, Transdermal Patch
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