Women's Mental Health: current projects

The Women's Mental Health Team coordinates a number of treatment and intervention trials focused on the gender differences in psychiatric care.

 
 

CURRENTLY RECRUITING STUDIES IN WMH

Double Blind Randomised Trial of Tibalone as an Adjunct to Standard Antidepressant Treatment for Relapsed and Persistent Depression in Peri- and Post-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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Genital Self-Image and Body Image Concerns

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NRAMP - The National Register of Antipsychotic Medication in Pregnancy

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Double Blind Randomised Investigation of Tibalone as an Adjunct to Standard Antidepressant Treatment for Relapsed and Persistent Depression in Peri- and Post-Menopausal Women

 

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)

 

 

Estradiol as a Treatment for Women with Borderline Personality Disorder

 

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

 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

 

Genital Self-Image and Body Image Concerns

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