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      Raloxifene as an Adjunctive Treatment for Postmenopausal Women With Schizophrenia: A 24-Week Double-Blind, Randomized, Parallel, Placebo-Controlled Trial

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          Abstract

          The potential therapeutic utility of estrogens in schizophrenia is increasingly being recognized. Raloxifene, a selective estrogen receptor modulator, appears to act similarly to estrogens on dopamine and serotonin brain systems. One previous trial by our team found that raloxifene was useful to improve negative, positive, and general psychopathological symptoms, without having the negative side effects of estrogens. In this study, we assess the utility of raloxifene in treating negative and other psychotic symptoms in postmenopausal women with schizophrenia exhibiting prominent negative symptoms. This was a 24-week, randomized, parallel, double-blind, placebo-controlled study. Patients were recruited from the inpatient and outpatient departments of Parc Sanitari Sant Joan de Déu, Hospital Universitari Institut Pere Mata, and Corporació Sanitària Parc Taulí. Seventy postmenopausal women with schizophrenia (DSM-IV) were randomized to either adjunctive raloxifene (38 women) or adjunctive placebo (32 women). Psychopathological symptoms were assessed at baseline and at weeks 4, 12, and 24 with the Positive and Negative Syndrome Scale (PANSS) and the Scale for the Assessment of Negative Symptoms (SANS). The addition of raloxifene (60mg/d) to regular antipsychotic treatment significantly reduced negative ( P = .027), general ( P = .003), and total symptomatology ( P = .005) measured with the PANSS during the 24-week trial, as compared to women receiving placebo. Also Alogia SANSS subscale improved more in the raloxifene ( P = .048) than the placebo group. In conclusion, raloxifene improved negative and general psychopathological symptoms, compared with antipsychotic medication alone, in postmenopausal women with schizophrenia. These data replicate our previous results with a larger sample and a longer follow-up. Trial registration: NCT01573637.

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          Author and article information

          Journal
          Schizophr Bull
          Schizophr Bull
          schbul
          schbul
          Schizophrenia Bulletin
          Oxford University Press (US )
          0586-7614
          1745-1701
          March 2016
          20 November 2015
          : 42
          : 2
          : 309-317
          Affiliations
          1 Parc Sanitari Sant Joan de Déu , Research and Development Unit, Sant Boi de Llobregat, Spain;
          2 Instituto de Salud Carlos III, Centro de Investigación en Red de Salud Mental (CIBERSAM) , Madrid, Spain;
          3 Catalan Group in Women’s Mental Health Research (GTRDSM) , Barcelona, Spain;
          4 Corporació Sanitària i Universitària Parc Taulí , Psychiatry Department, Sabadell, Spain;
          5 Hospital Universitari Institut Pere Mata, IISPV, Universitat Rovira i Virgili , Psychiatry Department, Reus, Spain;
          6 CAP EAE SALUT MENTAL , Andorra
          Author notes
          *To whom correspondence should be addressed; Par Sanitari Sant Joan de Déu, Universitat de Barcelona, Sant Boi de Llobregat (Barcelona), C/Doctor Antoni Pujadas, 42, 08830 Sant Boi de Llobregat, Spain; tel: 936-406-350, fax: 935-569-674, e-mail: jusall@ 123456pssjd.org
          †See Acknowledgments for list of collaborators.
          Article
          PMC4753610 PMC4753610 4753610
          10.1093/schbul/sbv149
          4753610
          26591005
          008b1619-136a-43e5-883f-3e5bbf8ef56c
          © The Author 2015. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oup.com
          History
          Page count
          Pages: 9
          Categories
          Regular Article

          negative symptoms,SERM,estrogen
          negative symptoms, SERM, estrogen

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