Abstract
Although acute psychotic symptoms are often reduced by antipsychotic treatment, many patients with schizophrenia are impaired in daily functioning due to the persistence of negative and cognitive symptoms. Raloxifene, a Selective Estrogen Receptor Modulator (SERM) has been shown to be an effective adjunctive treatment in schizophrenia. Yet, there is a paucity in evidence for raloxifene efficacy in men and premenopausal women. We report the design of a study that aims to replicate earlier findings concerning the efficacy of raloxifene augmentation in reducing persisting symptoms and cognitive impairment in postmenopausal women, and to extend these findings to a male and peri/premenopausal population of patients with schizophrenia. The study is a multisite, placebo-controlled, double-blind, randomised clinical trial in approximately 110 adult men and women with schizophrenia. Participants are randomised 1:1 to adjunctive raloxifene 120 mg or placebo daily during 12 weeks. The treatment phase includes measurements at three time points (week 0, 6 and 12), followed by a follow-up period of two years. The primary outcome measure is change in symptom severity, as measured with the Positive and Negative Syndrome Scale (PANSS), and cognition, as measured with the Brief Assessment of Cognition in Schizophrenia (BACS). Secondary outcome measures include social functioning and quality of life. Genetic, hormonal and inflammatory biomarkers are measured to assess potential associations with treatment effects. If it becomes apparent that raloxifene reduces psychotic symptoms and/or improves cognition, social functioning and/or quality of life as compared to placebo, implementation of raloxifene in clinical psychiatric practice can be considered.
Highlights
Schizophrenia is a common disorder, or rather a collection of several disorders, with heterogeneous combinations of symptoms and variable outcomes [1,2]
We describe the study protocol of a doubleblind, randomised, placebo-controlled clinical trial examining the effects of 12 weeks of raloxifene augmentation (120 mg/day) on symptom reduction and cognitive improvement in men and pre, peri- and postmenopausal women with a schizophrenia spectrum disorder
Safety data are evaluated by comparing incidences of key Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) between groups, e.g. hospitalisations
Summary
Schizophrenia is a common disorder, or rather a collection of several disorders, with heterogeneous combinations of symptoms and variable outcomes [1,2]. Two trials were performed in men and pre/perimenopausal women and/or men [29,30] These trials reported positive effects on symptoms [29] and cognition [30], the beneficial effects of raloxifene cannot be extrapolated to premenopausal women nor to men with schizophrenia without further testing. Such confirmation is essential before implementation of raloxifene in clinical practice can be advised. We describe the study protocol of a doubleblind, randomised, placebo-controlled clinical trial examining the effects of 12 weeks of raloxifene augmentation (120 mg/day) on symptom reduction and cognitive improvement in men and pre-, peri- and postmenopausal women with a schizophrenia spectrum disorder. Raloxifene augmentation is expected to reduce positive, negative and general symptoms and to improve cognitive, general and social functioning
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