The Monash Alfred Psychiatry Research Centre (MAPrc)

Complex Trauma Disorder is a pervasive pattern of instability of interpersonal relationships, self-image, and affects, and marked impulsivity that begins by early adulthood and is present in a variety of contexts. There is currently no approved pharmacological treatment for CTD.

A randomised double-blind placebo controlled investigation of adjunctive memantine in the treatment of symptoms of Complex Trauma Disorder (the Alison project).

(PI: Prof. J.Kulkarni) This study is testing a novel medication, Memantine, which we know from previous research to be safe and well-tolerated for its efficacy in improving symptoms of CTD. The aim of this study is to investigate the efficacy of ‘Memantine’ in reducing the severity of symptoms. We are looking for males and females aged 18–65 with symptoms consistent with CTD. This is a 12-week study where participants will chat fortnightly with their research team to monitor their progress.

A randomised placebo-controlled trial of estradiol for the treatment of women with Complex Trauma Disorder.

(PI. Prof. J. Kulkarni) This research project is investigating the use of hormones for the treatment of CTD. There is increasing evidence estradiol can help with emotional, cognitive, and behavioural symptom severity reduction. This is a 12-week trial of transdermal estradiol (100mcg twice weekly) vs. placebo as an adjunct to existing psychotropics for women aged 18–43 with CTD.

A phase II randomised, double-blinded, placebo-controlled parallel group trial to examine the efficacy and safety of 4 oral doses of BI 1358894 once daily over 12-week treatment period in patients with Complex Trauma Disorder.

(PI: Dr L.Chen) This is a 12-week trial involving both males and females aged 18–65 years with a diagnosis of CTD. The main objectives of this study are to provide proof-of-concept and dose-ranging data of the study drug, ‘BI 1358894’, compared to placebo to support dose selection for pivotal studies. All participants will continue on any existing stable psychotherapy treatment at the time of study entry. It is expected that treatment with BI 1358894 has the potential to improve affective symptoms and emotion control in patients with CTD.

Schizophrenia is a chronic and disabling serious mental illness. It has a lifetime prevalence of approximately one per cent, with almost equal distribution worldwide and comparable incidence between men and women. Treatment options remain less than optimal.

Bazedoxifene—a new selective estrogen receptor modulator treatment for schizophrenia: a double-blind, randomised, placebo-controlled trial.

(PI: Prof. J.Kulkarni) This research project is investigating the use of a selective estrogen receptor modulator (SERM) for the treatment of schizophrenia. The purpose of this project is to investigate the effects of Bazedoxifene (a new form of estrogen) as a treatment for schizophrenia. This is a 12-week trial of bazedoxifene vs. placebo as an adjunct to existing psychotropics for men and women aged 18-65, with schizophrenia. Participants will meet with a researcher fortnightly. Possible benefits may contribute to improvements in cognitive and other common symptoms. These can be seen as improvements in memory, concentration, mood, and other symptoms of the illness such as hearing voices or having unusual thoughts, thereby improving quality of life and general wellbeing.

A phase II randomised, double-blinded, placebo-controlled parallel group trial to examine the efficacy and safety of BI 425809 once daily with adjunctive Computerised Cognitive Training over 12 week treatment period in patients with schizophrenia

(PI: Dr L. Chen) This is a 12-week proof of concept study that will assess whether the investigative drug, ‘BI 425809’, aimed at improving cognition, is better than placebo in patients with schizophrenia. This study tests whether the study drug, together with brain training using a computer, improves mental functioning in males and females with schizophrenia aged 18–50. It is hypothesised the beneficial impact on cognition in patients on active treatment with BI 425809 will be further enhanced as a result of the increased cognitive activity achieved through computerised cognitive training.

Major Depressive Disorder is a debilitating disease that is difficult to treat, even when using systematic antidepressant strategies.

Double-Blind Randomised Investigation of Bazedoxifene and conjugated estrogen for Depression in Menopausal Women

(PI: Prof. J.Kulkarni) This research project is a 12-week trial investigating an experimental treatment medication for depression related to peri-menopause called ‘Duavive’, a combination medication containing Bazedoxifene and conjugated estrogens. The purpose of this study is to investigate the use of the medication combination Bazedoxifene and conjugated estrogen, a hormone replacement therapy, in the treatment of depression for women aged 45–65 with a first onset or relapse during the peri-menopausal phase that is still persisting.

A Phase II, 6-week, multi-centre, randomised, double-blind, double-dummy, placebo-controlled, parallel group trial with a quetiapine arm to evaluate the efficacy, tolerability and safety of oral BI 1358894 in patients with Major Depressive Disorder with inadequate response to antidepressants.

(PI: Dr L. Chen) This is a 6-week trial involving both males and females with Major Depressive Disorder (MDD) with inadequate response to ongoing treatment with an SSRI or an SNRI. The study drug ‘BI 1358894’ has the potential to improve affective symptoms and emotion control. The main objectives of this trial are to provide proof of concept and dose-ranging data of the study drug compared to placebo in patients with Major Depressive Disorder (MDD) to support dose selection for pivotal studies.

Transcranial Magnetic Stimulation for depression

(PI: Dr L. Chen) Depression is a common mental health disorder affecting more than one million Australians at any given time. It is estimated one in seven Australians will experience depression in their lifetime. Despite its prevalence, depression can be difficult to treat. Treatment options are even more limited for women experiencing hormonally driven depression during and after pregnancy. Medications can induce emotional blunting, which threatens early mother-baby bonding. Many women also avoid antidepressants so they do not transmit medication through the placenta and breastmilk to their growing baby. This leads to poor short- and long-term outcomes, and unacceptable risks, for both mother and baby.

Transcranial magnetic stimulation (TMS) is an effective and evidence-based therapy for treatment-resistant depression with minimal side effects. TMS lends itself well to treating depression in women during and after pregnancy as it does not circulate chemicals into the bloodstream, protecting growing babies from the negative impacts of medications.

The TMS Clinical Research Unit aims to launch impactful clinical research to optimise and innovate TMS therapy (lowering its cost and increasing access for depressed patients who would otherwise not receive this lifesaving therapy) and validate TMS as a safe and effective treatment for women experiencing depression due to hormonal changes – particularly at crucial stages in the reproductive cycle, which can result in long-lasting harm to mothers and children.

We invite you on this journey in partnership to support TMS research that transforms the lives of people with depression across Australia and beyond.

Contact Dr Leo Chen at leo.chen@monash.edu to find out more.