title: Piloting the effective therapeutic dose of adjunctive selective estrogen receptor modulator treatment in postmenopausal women with schizophrenia.
abstract: Estrogen treatment may enhance the recovery of schizophrenia in women. However, adverse effects on uterine and breast tissue and other physical side effects may limit the long-term therapeutic use of estrogen. Raloxifene hydrochloride is a selective estrogen receptor modulator that acts as an estrogen antagonist in breast tissue and may have agonistic actions in the brain, potentially offering mental health benefits with few estrogenic side effects. To provide an indication of the potential therapeutic dose for raloxifene hydrochloride in postmenopausal women with schizophrenia, this study pools data from an ongoing randomized controlled trial of adjunctive 120 mg/day oral raloxifene hydrochloride (n=13) versus oral placebo (n=13), with data from a previous pilot study administering 60 mg/day raloxifene hydrochloride (n=9). Analysis of variance found significant interaction effects for total (p=.01) and general (p=.02) Positive and Negative Syndrome Scale (PANSS) symptomatology. Participants randomized to receive 120 mg/day raloxifene hydrochloride experienced a significantly more rapid recovery of total and general psychotic symptoms compared to both 60 mg/day raloxifene hydrochloride and placebo. The demonstrated benefit of adjunctive treatment with 120 mg/day raloxifene hydrochloride offers support for the potential role of this selective estrogen receptor modulator in treating postmenopausal women with schizophrenia.
authors.affiliation: Monash Alfred Psychiatry Research Centre, The Alfred and Monash University School of Psychology, Psychiatry and Psychological Medicine, Melbourne, Australia. j.kulkarni@alfred.org.au
authors.forename: Jayashri
authors.initials: J
authors.lastname: Kulkarni
authors.forename: Caroline
authors.initials: C
authors.lastname: Gurvich
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Lee
authors.forename: Heather
authors.initials: H
authors.lastname: Gilbert
authors.forename: Emmy
authors.initials: E
authors.lastname: Gavrilidis
authors.forename: Anthony
authors.initials: A
authors.lastname: de Castella
authors.forename: Michael
authors.initials: M
authors.lastname: Berk
authors.forename: Seetal
authors.initials: S
authors.lastname: Dodd
authors.forename: Paul B
authors.initials: PB
authors.lastname: Fitzgerald
authors.forename: Susan R
authors.initials: SR
authors.lastname: Davis
mesh_terms: D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008875:Middle Aged; D010865:Pilot Projects; D010919:Placebos; D017698:Postmenopause / Q000187:drug effects*; 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; D016896:Treatment Outcome
chemical_list: D010919:Placebos; D020845:Selective Estrogen Receptor Modulators; D020849:Raloxifene Hydrochloride