HER Centre Australia, established as a formal Monash University Centre in 2022 stands for Health, Education, and Research in Women's Mental Health. For more information about HER Centre Australia, visit the HER Centre Australia website - www.monash.edu/her-centre
Mental illness has many gender-specific aspects that clinical research has not always addressed. For example, in conditions such as schizophrenia, the age of onset and pattern of symptoms commonly seen is different for women and men. Women and men may also respond differently to medications or other treatments. In addition, changes in the level of sex hormones such as estrogen are known to affect symptoms.
The HER Centre Australia team is working on numerous aspects of women’s mental health, the experiences of women with mental illness and potential options for treatment.
One particular focus of our research is the role of the neuroendocrine system in mental illnesses, and specifically the use of female hormones to improve the results of treatment. We are conducting ground-breaking research into the use of estrogen to improve symptoms in schizophrenia and the use of selective brain estrogens in postmenopausal women. We are also exploring possible links between the oral contraceptive pill and depression.
To find out more about current projects click here. For information about our PTSD clinical trial, please click here
Research Manager
Anthony de Castella
Emmy Gavrilidis
The HER Centre Australia team coordinates a number of treatment and intervention trials focused on the gender differences in psychiatric care.
CURRENTLY RECRUITING STUDIES IN WMH |
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Double-Blind Randomised Investigation of Bazedoxifene and conjugated estrogen for Depression in Menopausal Women.Double-Blind Randomised Investigation of Bazedoxifene and conjugated estrogen for Depression in Menopausal Women. |
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The Alison Project: A randomised double-blind placebo controlled investigation of adjunctive memantine in the treatment of symptoms of complex trauma disorder (also known as borderline personality disorder) |
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Estradiol as a Treatment for Women with Borderline Personality Disorder |
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Bazedoxifene – A New Selective Estrogen Receptor Modulator Treatment for Women with Schizophrenia |
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The Damian Project – The Use Bazedoxifene as a Potential Treatment for Men with Schizophrenia |
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Genital Self-Image and Body Image Concerns |
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We would like to thank First Response for their sponsorship for part of this study.
Estradiol as a Treatment for Women with Borderline Personality Disorder
Background:
Borderline Personality Disorder (BPD) is a serious and highly prevalent (5.9%) psychiatric disorder, affecting women more than men. BPD sufferers experience severe emotional instability, social and occupational dysfunction, and engage in chronic self-mutilation and suicidal behaviours, with associated high levels of mortality, morbidity, and health service use. BPD patients are a complex group that are challenging to treat. Current psychological treatments are expensive and difficult for BPD patients to access, and there is currently no clearly designated pharmacotherapy. Underpinned by psychosocial causes, childhood trauma is reported in most patients (>80%) and is linked to abnormalities in the development of the neuroendocrine axes. Significantly, cyclical fluctuations in ovarian hormones affect emotional and cognitive behaviours relevant to BPD. As such, this indicates the neuroendocrine system as a potential therapeutic target for the treatment of BPD symptoms.
Aim:
To determine whether estradiol is effective in treating symptoms of BPD, and specific symptom domains including emotional regulation, cognition, mood and quality of life, as well as biological markers.
Participants:
Women aged between 18-43, who have a current diagnosis of BPD or experience symptoms consistent with BPD 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 the Monash Alfred Psychiatry research centre. Participants will be randomly selected to receive daily either 1) transdermal estradiol 100mcg twice weekly patch, or 2) inactive placebo. Participants will touch base with their study coordinators every two weeks to monitor mood symptoms and adverse events.
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
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 18-65, 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
Genital Self-Image and Body Image Concerns
Over the last 10 to 15 years, we have seen a rapid increase in the number of adolescent and adult women requesting cosmetic genital surgery. Professional medical organisations throughout the Western world have expressed serious concerns about this trend. As the American College of Obstetricians and Gynaecologists state, cosmetic genital surgery is not medically indicated, and long term safety and effectiveness data are lacking. Potential complications include infection, altered sensation, dyspareunia, adhesions, and scarring.
Research has shown the primary motivation for these surgeries is aesthetic concern. Our research has focused on investigating the psychological and sociocultural factors underpinning this increase in genital appearance dissatisfaction in women. We firstly examined these factors in adult women, but have subsequently shifted our attention to adolescent girls as this is usually the period when girls first start to develop these concerns. We are also in the process of pilot testing a therapeutic mobile app, based on cognitive behavioural therapy principles, which aims to alleviate women’s genital appearance concerns. We hope that this app will provide an alternative to unproven cosmetic genital surgery and potentially be disseminated nationally and internationally.
For more information, please contact Dr Gemma Sharp via email at gemma.sharp@monash.edu or by phone on (03) 9076 5167
The Damian Project - The Use of Bazadoxifene as a Potential Treatment for Men with Schizophrenia
Thanks to the generous support of the Mohr family, and in honour of the memory of Damian Mohr, MAPrc is privileged to be able to conduct this exiciting new trial to explore the use of Bazadoxifene, a Selective Estrogen Receptor Modulator (SERM), as a potential treatment for men with Schizophrenia.
Study Aim
To study the effect of adjunctive Bazedoxifene – a selective estrogen receptor modulator (SERM) in a double blind, placebo-controlled adjunctive study in the treatment of men with schizophrenia. All patients receive standardized antipsychotic medication.
Trial Background
Despite advances in the treatment of schizophrenia, pharmacotherapy remains sub-optimal, and the prognosis for many patients is poor. We have pioneered work showing that estradiol has a positive role in the treatment of psychosis symptoms and cognitive deficits seen in people with schizophrenia. However, with the longer-term work from studies such as the Women’s Health Initiative (1), it has become clear that long-term use of estradiol with progesterone may have associated increased risks of breast and other cancers. Hence, we began working with the Selective Estrogen Receptor Modulator – raloxifene, which appears to be safer for longer term use with respect to the development of breast and other cancers. Building on our and others work, raloxifene used as an adjunctive treatment in schizophrenia appears to produce inconsistent and varying responses in different sub-populations; gender, menopausal status, age, drug dose and delivery mode. We now propose to conduct a double-blind, randomized, placebo-controlled trial of a third generation SERM – Bazedoxifene – which is 4 times more selective for the alpha than the beta oestrogen receptor subtype. Bazedoxifene appears to be safer with respect to long term use than older SERMs, has additional actions on the glucocorticoid receptor, and together this different pharmacology speculatively has greater potential than other SERMs to impact favorably on both psychosis symptoms and cognition in men and women with schizophrenia. This study will test 100 men to determine if Bazedoxifene, as an adjunctive hormone modulator, is effective for positive and cognitive symptoms of schizophrenia.
Trial Design
The trial will follow the parallel comparison design consisting of two arms over 12 weeks (treatment x time). Participants will be randomized to:
1. Bazedoxifene 40mg oral / day
2. Oral placebo (an inert substance with no active ingredients)
Trial Subjects
100 males with a current diagnosis of Schizophrenia, Schizoaffective and Schizophreniform disorder according to the Diagnostic and Statistical Manual (DSM-5) of the American Psychiatric Association.
This trial has Ethics Committee approval from the Alfred Research and Ethics Committee and the Monash University Human Research Ethics Committee and is currently recruiting
To Participate in this Trial or to find out more please email our team at: participate.maprc@monash.edu or call us on +61 3 9076 6564
Download a Trial Flyer HERE