Piloting the effective therapeutic dose of adjunctive selective estrogen receptor modulator treatment in postmenopausal women with schizophrenia

Kulkarni, Jayashri; Gurvich, Caroline; Lee, Stuart J.; Gilbert, Heather; Gavrilidis, Emmy; de Castella, Anthony; Berk, Michael; Dodd, Seetal; Fitzgerald, Paul B.; Davis, Susan R.

doi:10.1016/j.psyneuen.2010.01.014

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Volume 35, Issue 8 , Pages 1142-1147, September 2010

Piloting the effective therapeutic dose of adjunctive selective estrogen receptor modulator treatment in postmenopausal women with schizophrenia

Jayashri Kulkarni
- Monash Alfred Psychiatry Research Centre, The Alfred and Monash University School of Psychology, Psychiatry and Psychological Medicine, Melbourne, Australia
- Corresponding author at: Monash Alfred Psychiatry Research Centre, Level One, Old Baker Building, The Alfred Hospital, Commercial Rd, Melbourne 3004, Victoria, Australia. Tel.: +61 3 9076 6924; fax: +61 3 9076 8545.
Caroline Gurvich
- Monash Alfred Psychiatry Research Centre, The Alfred and Monash University School of Psychology, Psychiatry and Psychological Medicine, Melbourne, Australia
Stuart J. Lee
- Monash Alfred Psychiatry Research Centre, The Alfred and Monash University School of Psychology, Psychiatry and Psychological Medicine, Melbourne, Australia
Heather Gilbert
- Monash Alfred Psychiatry Research Centre, The Alfred and Monash University School of Psychology, Psychiatry and Psychological Medicine, Melbourne, Australia
Emmy Gavrilidis
- Monash Alfred Psychiatry Research Centre, The Alfred and Monash University School of Psychology, Psychiatry and Psychological Medicine, Melbourne, Australia
Anthony de Castella
- Monash Alfred Psychiatry Research Centre, The Alfred and Monash University School of Psychology, Psychiatry and Psychological Medicine, Melbourne, Australia
Michael Berk
- Department of Clinical and Biomedical Sciences, Barwon Health, University of Melbourne, Geelong, Australia
- Orygen Research Centre, Parkville, Australia
- Mental Health Research Institute of Victoria, Parkville, Australia
Seetal Dodd
- Department of Clinical and Biomedical Sciences, Barwon Health, University of Melbourne, Geelong, Australia
Paul B. Fitzgerald
- Monash Alfred Psychiatry Research Centre, The Alfred and Monash University School of Psychology, Psychiatry and Psychological Medicine, Melbourne, Australia
Susan R. Davis
- Women's Health Program, Department of Medicine, Monash University, Australia

Received 7 December 2009; received in revised form 15 January 2010; accepted 26 January 2010.

Summary

Estrogen treatment may enhance the recovery of schizophrenia in women. However, adverse effects on uterine and breast tissue and other physical side effects may limit the long-term therapeutic use of estrogen. Raloxifene hydrochloride is a selective estrogen receptor modulator that acts as an estrogen antagonist in breast tissue and may have agonistic actions in the brain, potentially offering mental health benefits with few estrogenic side effects. To provide an indication of the potential therapeutic dose for raloxifene hydrochloride in postmenopausal women with schizophrenia, this study pools data from an ongoing randomized controlled trial of adjunctive 120mg/day oral raloxifene hydrochloride (n=13) versus oral placebo (n=13), with data from a previous pilot study administering 60mg/day raloxifene hydrochloride (n=9). Analysis of variance found significant interaction effects for total (p=.01) and general (p=.02) Positive and Negative Syndrome Scale (PANSS) symptomatology. Participants randomized to receive 120mg/day raloxifene hydrochloride experienced a significantly more rapid recovery of total and general psychotic symptoms compared to both 60mg/day raloxifene hydrochloride and placebo. The demonstrated benefit of adjunctive treatment with 120mg/day raloxifene hydrochloride offers support for the potential role of this selective estrogen receptor modulator in treating postmenopausal women with schizophrenia.