title: Raloxifene as an adjunctive treatment for postmenopausal women with schizophrenia: a double-blind, randomized, placebo-controlled trial.
abstract: OBJECTIVE
  The potential therapeutic utility of estrogens in schizophrenia is increasingly being recognized. Raloxifene, a selective estrogen receptor modulator, appears to act similarly to conjugated estrogens on dopamine and serotonin brain systems and may be a better option since it lacks the possible negative effects of estrogen on breast and uterine tissue. In this study, we assess the utility of raloxifene as an adjunctive treatment for negative symptoms and other psychotic symptoms in postmenopausal women with schizophrenia.
  
  
  METHODS
  This was a 12-week, double-blind, randomized, placebo-controlled study. Patients were recruited from both the inpatient and outpatient departments of Parc Sanitari Sant Joan de Déu, Barcelona, Spain, and Corporació Sanitària Parc Taulí, Sabadell, Spain. Thirty-three postmenopausal women with schizophrenia (DSM-IV criteria) who exhibited prominent negative symptoms were randomized to either adjunctive raloxifene (16 women; mean age = 60.14 years, SD = 6.41 years) or adjunctive placebo (17 women; mean age = 62.66 years, SD = 4.54 years) for 12 weeks. The period of recruitment lasted from January 2005 through June 2009. Psychopathological symptoms were assessed at baseline and weeks 4, 8, and 12 by means of the Positive and Negative Syndrome Scale.
  
  
  RESULTS
  The addition of raloxifene (60 mg/d) to regular antipsychotic treatment significantly reduced negative (P = .044), positive (P = .031), and general psychopathological (P = .045) symptoms during the 12-week trial as compared with women receiving placebo.
  
  
  CONCLUSIONS
  Raloxifene as an adjuvant treatment in postmenopausal women with schizophrenia who exhibit prominent negative symptoms appears to be useful in improving negative, positive, and general psychopathological symptoms. If more extensive and longer-term studies confirm and expand upon these positive results, the use of raloxifene could be recommended in postmenopausal patients with schizophrenia.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01041092.
authors: Parc Sanitari Sant Joan de Déu C/Antoni Pujadas, 42 Sant Boi de Llobregat 08830, Barcelona, Spain. jusall@pssjd.org
authors: Judith
authors: J
authors: Usall
authors: Elena
authors: E
authors: Huerta-Ramos
authors: Raquel
authors: R
authors: Iniesta
authors: Jesús
authors: J
authors: Cobo
authors: Susana
authors: S
authors: Araya
authors: Mercedes
authors: M
authors: Roca
authors: Antoni
authors: A
authors: Serrano-Blanco
authors: Fernando
authors: F
authors: Teba
authors: Susana
authors: S
authors: Ochoa
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; D010919:Placebos; D017698:Postmenopause / Q000187:drug effects / Q000523:psychology; D011569:Psychiatric Status Rating Scales; D020849:Raloxifene Hydrochloride / Q000009:adverse effects / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy*; D020845:Selective Estrogen Receptor Modulators / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D010919:Placebos; D020845:Selective Estrogen Receptor Modulators; D020849:Raloxifene Hydrochloride