title: A Placebo-Controlled Study of Raloxifene Added to Risperidone in Men with Chronic Schizophrenia.
abstract: Selective estrogen receptor modulators (SERMs) such as raloxifene have already shown beneficial effects on negative, positive and general psychopathology symptoms in postmenopausal women with schizophrenia. The purpose of the present investigation was to assess the efficacy of raloxifene as an adjuvant agent in the treatment of men with chronic schizophrenia in an 8-week double-blind and placebo-controlled trial. In a randomized, double-blind and placebo-controlled study, forty-six male patients diagnosed with schizophrenia (DSM-IV-TR), were randomized to either raloxifene (120 mg/day) or placebo in addition to risperidone (6 mg/day) for eight weeks. The assessment was performed using the positive and negative symptom scale (PANSS) at baseline, and at weeks 2, 4, 6 and 8. Extrapyramidal symptom rating scale (ESRS) at baseline, weeks 1, 2, 4, 6, 8 and Hamilton depression rating scale (HDRS) at baseline and week 8 were also used to assess extrapyramidal symptoms and depression simultaneously. Forty-two patients completed the trial. The raloxifene group showed significantly greater improvement on the negative subscale (P<0.001), the general psychopathology subscale (P=0.002) and total PANSS score (P<0.001) in comparison to the placebo group at the endpoint. There was no significant difference in the reduction of positive symptoms score between the two group (P=0.525). Extrapyramidal symptom rating scale and Hamilton depression rating scale and frequency of other adverse effects were comparable between two groups.This study indicates raloxifene as a potential adjunctive treatment strategy for chronic schizophrenia in men.
authors.affiliation: Razi Hospital, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran. s.akhond@neda.net.
authors.forename: Mohammad-Reza
authors.initials: MR
authors.lastname: Khodaie-Ardakani
authors.affiliation: Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran. s.akhond@neda.net.
authors.forename: Mohsen
authors.initials: M
authors.lastname: Khosravi
authors.affiliation: Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran. s.akhond@neda.net.
authors.forename: Razieh
authors.initials: R
authors.lastname: Zarinfard
authors.affiliation: Razi Hospital, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran. s.akhond@neda.net.
authors.forename: Somayeh
authors.initials: S
authors.lastname: Nejati
authors.affiliation: Razi Hospital, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran. s.akhond@neda.net.
authors.forename: Ali
authors.initials: A
authors.lastname: Mohsenian
authors.affiliation: Department of Medical Genetics, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran. s.akhond@neda.net.
authors.forename: Mina
authors.initials: M
authors.lastname: Tabrizi
authors.affiliation: Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran. s.akhond@neda.net.
authors.forename: Shahin
authors.initials: S
authors.lastname: Akhondzadeh
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D003863:Depression / Q000188:drug therapy; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D006801:Humans; D008297:Male; D011569:Psychiatric Status Rating Scales; D020849:Raloxifene Hydrochloride / Q000008:administration & dosage / Q000627:therapeutic use*; D018967:Risperidone / Q000008:administration & dosage / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D020849:Raloxifene Hydrochloride; D018967:Risperidone