Adjunctive SERM Hormone Treatment for Men and Women with Schizophrenia and Schizoaffective Disorder

Background

Increasing evidence points to the protective role of estrogen in the brain, and for its positive effect on the symptoms of schizophrenia and schizoaffective disorder. However, adverse effects on breast and uterine tissue in females, and feminisation of males, limit the long-term therapeutic use of estrogen in this population.

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

Raloxifene for men as well as for women?

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. The advantage of using raloxifene instead of estrogen in men is that the beneficial effects of estrogen can be experienced in the brain without the feminising side effects typically associated with hormone treatments.

Aim

To examine whether adding raloxifene 120mg/day to regular antipsychotic treatment can improve psychotic symptoms, and mood and cognitive functioning, for men and women with schizophrenia or schizoaffective disorder.

Participants

Men and women who are 18+, who have been diagnosed with schizophrenia or schizoaffective disorder, are invited to take part in this study.

Methods

This study is a 12-week randomised controlled trial. Participants will be randomly selected to receive daily either 1) 120mg raloxifene, or 2) inactive placebo. Participants will meet with the study coordinator, Dr Jasmin Grigg, every two weeks to monitor psychotic and mood symptoms, and memory functioning will be assessed twice during the study. The occurrence of any unwanted side effects is also monitored.

Following completion of the trial, participants meet with the chief investigator, Professor Jayashri Kulkarni, to discuss their study outcomes.

Reimbursement

Participants will be reimbursed for their time and travel can be negotiated.

Project status

The study is currently recruiting participants.

Study coordinator

Dr Natalie Thomas

For more information, please contact Natalie Thomas on (03) 9076 5033 or via email natalie.thomas@monash.edu 

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

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