Bazedoxifene – A New Selective Estrogen Receptor Modulator Treatment for Women with Schizophrenia

 Bazedoxifene – A New Selective Estrogen Receptor Modulator Treatment for Women with Schizophrenia

Background:

Although more commonly associated with women, estrogen is also a naturally occurring hormone in the bodies of men, and is already used clinically to reverse bone loss, enhance cardiovascular function, and treat prostate cancer. However, increasing evidence points to the protective role of estrogen in the brain, and for its positive effects on the symptoms of schizophrenia and schizoaffective disorder. However, adverse effects on breast and uterine tissue in females limit therapeutic use of estrogen in this population.


Bazedoxifene is a new hormone treatment that belongs to a group of medications called Selective Estrogen Receptor Modulators (SERMs). Bazedoxifene is thought to have positive estrogenic effects in the brain without affecting peripheral body tissues, thus offering a longer term treatment approach with potential mental health and cognitive benefits.


Aim:


To compare the efficacy of adjunctive bazedoxifene against adjunctive placebo in treating psychosis symptoms and improving cognition in women with schizophrenia.


Participants:

Women aged between 18-45, who have been diagnosed with schizophrenia and schizoaffective disorder, and are not currently using any hormonal therapy are invited to take part in this study.


Methods:

This study is a 12-week randomised, double-blind, placebo controlled trial that will be conducted at two sites in Melbourne - the lead site is the Monash Alfred Psychiatry research centre and a second site is the Monash Medical Centre. Participants will be randomly selected to receive daily either 1) 40mg bazedoxifene, or 2) inactive placebo. Participants will touch base with their study coordinators every two weeks to monitor psychotic and mood symptoms, and blood samples will be collected at three time-points during the study. The occurrence of any unwanted side effects will also be monitored.

Project status

If you are interested in learning more about this study please contact the team to register an expression of interest

For more information, please contact the Women’s Mental Health Division via email at maprc.wmhresearch@monash.edu