title: Raloxifene as an Adjunctive Treatment for Postmenopausal Women With Schizophrenia: A 24-Week Double-Blind, Randomized, Parallel, Placebo-Controlled Trial.
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 (60 mg/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.
  
  
  BACKGROUND
  NCT01573637.
authors.affiliation: jusall@pssjd.org.
authors.forename: Judith
authors.initials: J
authors.lastname: Usall
authors.forename: Elena
authors.initials: E
authors.lastname: Huerta-Ramos
authors.forename: Javier
authors.initials: J
authors.lastname: Labad
authors.affiliation: Catalan Group in Women's Mental Health Research (GTRDSM), Barcelona, Spain; Corporació Sanitària i Universitària Parc Taulí, Psychiatry Department, Sabadell, Spain;
authors.forename: Jesús
authors.initials: J
authors.lastname: Cobo
authors.affiliation: Parc Sanitari Sant Joan de Déu, Research and Development Unit, Sant Boi de Llobregat, Spain;
authors.forename: Christian
authors.initials: C
authors.lastname: Núñez
authors.affiliation: Hospital Universitari Institut Pere Mata, IISPV, Universitat Rovira i Virgili, Psychiatry Department, Reus, Spain;
authors.forename: Marta
authors.initials: M
authors.lastname: Creus
authors.affiliation: Catalan Group in Women's Mental Health Research (GTRDSM), Barcelona, Spain; Corporació Sanitària i Universitària Parc Taulí, Psychiatry Department, Sabadell, Spain; CAP EAE SALUT MENTAL, Andorra.
authors.forename: Gemma García
authors.initials: GG
authors.lastname: Parés
authors.affiliation: Parc Sanitari Sant Joan de Déu, Research and Development Unit, Sant Boi de Llobregat, Spain;
authors.forename: Daniel
authors.initials: D
authors.lastname: Cuadras
authors.affiliation: Instituto de Salud Carlos III, Centro de Investigación en Red de Salud Mental (CIBERSAM), Madrid, Spain; Hospital Universitari Institut Pere Mata, IISPV, Universitat Rovira i Virgili, Psychiatry Department, Reus, Spain;
authors.forename: José
authors.initials: J
authors.lastname: Franco
authors.affiliation: Parc Sanitari Sant Joan de Déu, Research and Development Unit, Sant Boi de Llobregat, Spain;
authors.forename: Eva
authors.initials: E
authors.lastname: Miquel
authors.affiliation: Instituto de Salud Carlos III, Centro de Investigación en Red de Salud Mental (CIBERSAM), Madrid, Spain; Hospital Universitari Institut Pere Mata, IISPV, Universitat Rovira i Virgili, Psychiatry Department, Reus, Spain;
authors.forename: Julio César
authors.initials: JC
authors.lastname: Reyes
authors.affiliation: Parc Sanitari Sant Joan de Déu, Research and Development Unit, Sant Boi de Llobregat, Spain;
authors.forename: Mercedes
authors.initials: M
authors.lastname: Roca
mesh_terms: D000368:Aged; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010919:Placebos; D017698:Postmenopause; D020849:Raloxifene Hydrochloride / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D012559:Schizophrenia / Q000188:drug therapy*; D020845:Selective Estrogen Receptor Modulators / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*
chemical_list: D014150:Antipsychotic Agents; D010919:Placebos; D020845:Selective Estrogen Receptor Modulators; D020849:Raloxifene Hydrochloride
keywords: SERM; estrogen; negative symptoms