Adjuvant Raloxifene Treatment Promising For Women With Refractory Schizophrenia

MedicalResearch.com Interview with:

Prof. Jayashri Kulkarni

Prof. Jayashri Kulkarni

Professor Jayashri Kulkarni MBBS, MPM,
FRANZCP, PhD

Director, Monash Alfred Psychiatry research centre
Vic Australia

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Schizophrenia is a complex psychiatric disorder and many patients are not able to achieve remission on the available treatments. There are clear sex differences in many aspects of the illness, which not only implicates a role for the sex hormone estrogen in schizophrenia, but also highlights the need for sex-specific treatments.

Our group has conducted many clinical trials using adjunctive estradiol treatment, with excellent improvement in psychotic symptoms- however, there can be physical side effects with longer term estradiol use. Raloxifene and other selective estrogen receptor modulators ( SERMs) – the so-called “brain estrogens”, with their more specific brain impacts and less body side effects – provide an option to use longer term estrogen in people with refractory schizophrenia. We conducted the first ever pilot study of raloxifene in 2010, and now present findings from a bigger study of adjunctive raloxifene treatment in schizophrenia.

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We conducted a 12- week double-blind placebo-controlled clinical trial in 56 older women with refractory schizophrenia (mean duration of illness was 24 years). Participants were randomised to either adjunctive placebo or adjunctive daily 120 mg oral raloxifene hydrochloride therapy and were assessed on a fortnightly basis. Results showed raloxifene produced a significantly greater reduction in overall symptoms (as measured by the Positive and Negative Syndrome Scale, PANSS total score) relative to placebo, and resulted in an increased probability of a clinical response.

MedicalResearch.com: What should readers take away from your report?

Response: Our research has shown that for women with refractory schizophrenia, adjunctive raloxifene hydrochloride therapy (at 120 mg/d) is a promising, well-tolerated agent that can reduce overall symptom severity.
Raloxifene has significant potential for application in clinical practice, with appropriate screening and monitoring for associated risk factors such as smoking and thromboembolic events.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: Further research to determine the longer-term safety and efficacy of high-dosage raloxifene in women with schizophrenia is needed. Functional neuroimaging with positron emission tomography using a specific estrogen radioligand is required to map raloxifene’s effects in the central nervous system in patients with schizophrenia, in order to better understand its therapeutic mechanism.

MedicalResearch.com: Is there anything else you would like to add?

Response: This investigation represents an important development regarding the evidence base for central nervous system estrogenic agents and schizophrenia tractability.
Raloxifene is an available medication that may be of benefit for older women with persistent schizophrenia.

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