The Damian Project - Bazadoxefine Treatment for Male Schizophrenia


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: or call us on +61 3 9076 6564

Download a Trial Flyer HERE








 MAPrc Multidisciplinary Alfred Psychiatry Research Centre, Level 4, 607 St Kilda Road, Melbourne 3004