Estradiol for treatment-resistant schizophrenia: a large-scale randomized-controlled trial in women of child-bearing age

Kulkarni, J., Gavrilidis, E., Wang, W., Worsley, R., Fitzgerald, P.B., Gurvich, C., Van Rheenen, T., Berk, M. and Burger, H. 2015, Estradiol for treatment-resistant schizophrenia: a large-scale randomized-controlled trial in women of child-bearing age, Molecular psychiatry, vol. 20, pp. 695-702, doi: 10.1038/mp.2014.33.

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Title Estradiol for treatment-resistant schizophrenia: a large-scale randomized-controlled trial in women of child-bearing age
Author(s) Kulkarni, J.
Gavrilidis, E.
Wang, W.ORCID iD for Wang, W.
Worsley, R.
Fitzgerald, P.B.
Gurvich, C.
Van Rheenen, T.
Berk, M.ORCID iD for Berk, M.
Burger, H.
Journal name Molecular psychiatry
Volume number 20
Start page 695
End page 702
Total pages 8
Publisher Nature Publishing Group
Place of publication London, Eng.
Publication date 2015
ISSN 1476-5578
Summary Many women with schizophrenia remain symptomatic despite optimal use of current therapies. While previous studies suggest that adjunctive oestrogen therapy might be effective, large-scale clinical trials are required before clinical applications are possible. This study is the first large-scale randomized-controlled trial in women with treatment-resistant schizophrenia. This Definitive Oestrogen Patch Trial was an 8-week, three-arm, double-blind, randomized-controlled trial conducted between 2006 and 2011. The 183 female participants were aged between 18 and 45 (mean=35 years), with schizophrenia or schizoaffective disorder and ongoing symptoms of psychosis (Positive and Negative Syndrome Scale, PANSS score>60) despite a stable dose of antipsychotic medication for at least 4 weeks. Mean duration of illness was more than 10 years. Participants received transdermal estradiol 200 μg, transdermal estradiol 100 μg or an identical placebo patch. For the 180 women who completed the study, the a priori outcome measure was the change in PANSS score measured at baseline and days 7, 14, 28 and 56. Cognition was assessed at baseline and day 56 using the Repeatable Battery of Neuropsychological Status. Data were analysed using latent growth curve modelling. Both estradiol groups had greater decreases in PANSS positive, general and total symptoms compared with the placebo group (P<0.01), with a greater effect seen for 200 μg than 100 μg estradiol. The largest effect size was for the positive subscale of PANSS in the estradiol 200 μg treatment group (effect size 0.44, P<0.01). This study shows estradiol is an effective and clinically significant adjunctive therapy for women with treatment-resistant schizophrenia, particularly for positive symptoms.Molecular Psychiatry advance online publication, 15 April 2014; doi:10.1038/mp.2014.33.
Language eng
DOI 10.1038/mp.2014.33
Field of Research 110999 Neurosciences not elsewhere classified
Socio Economic Objective 920410 Mental Health
HERDC Research category C1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2015, Nature Publishing Group
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