Raloxifene augmentation in men and women with a schizophrenia spectrum disorder: A study protocol

• DOI: 10.1016/j.conctc.2020.100681
• Publication Date: 2020-11-25T12:08:57Z
• Authors: Bodyl A. Brand; Janna N. de Boer; Sebastianus B.J. ...; Margot I.E. Slot; Bieke De Wilde; Kirsten C.E.E.R. ...; Angelique J. Goverde; P. Roberto Bakker; Machteld C. Marcelis; Koen P. Grootens; Jurjen J. Luykx; Sophie M. Heringa; Cynthia Shannon W...; Iris E.C. Sommer; Thomas W. Weickert
• Keywords: Raloxifene

Although acute psychotic symptoms are often reduced by antipsychotic treatment, many patients with schizophrenia impaired in daily functioning due to the persistence of negative and cognitive symptoms. Raloxifene, a Selective Estrogen Receptor Modulator (SERM) has been shown be an effective adjunctive treatment schizophrenia. Yet, there is paucity evidence for raloxifene efficacy men premenopausal women. We report design study that aims replicate earlier findings concerning augmentation reducing persisting impairment postmenopausal women, extend these male peri/premenopausal population The multisite, placebo-controlled, double-blind, randomised clinical trial approximately 110 adult women Participants 1:1 120 mg or placebo during 12 weeks. phase includes measurements at three time points (week 0, 6 12), followed follow-up period two years. primary outcome measure change symptom severity, as measured Positive Negative Syndrome Scale (PANSS), cognition, Brief Assessment Cognition Schizophrenia (BACS). Secondary measures include social quality life. Genetic, hormonal inflammatory biomarkers assess potential associations effects. If it becomes apparent reduces and/or improves life compared placebo, implementation psychiatric practice can considered.