Table 1.
Most relevant studies investigating the efficacy of raloxifene in the treatment of postmenopausal schizophrenia women (n = 8).
| Authors and Year of Publication | Study Design | Comparison Groups | Psychometric Instruments | Findings |
|---|---|---|---|---|
| Kulkarni et al., 2010 [32] | 12-week double-blind randomized controlled trial | Raloxifene 120 mg/day (n = 13) vs. raloxifene 60 mg/day (n = 9) vs. placebo (n = 13) | Psychopathology: PANSS and MADRS (at baseline, weeks 2, 4, 6, 8, 10, and 12) | Raloxifene 120 mg/day was associated with improvement in PANSS total and general symptoms compared to raloxifene 60 mg/day and placebo |
| Usall et al., 2011 [34] | 12-week double-blind randomized placebo-controlled trial | Raloxifene 60 mg/day (n = 16) vs. placebo (n = 17) | Psychopathology: PANSS (at baseline, weeks 4 and 12) | Raloxifene 60 mg/day associated with improvement in positive, negative, and general psychotic symptoms |
| Kianimehr et al., 2014 [31] | 8-week parallel-group placebo-controlled trial | Risperidone 6 mg/day plus raloxifene 120 mg/day (n = 23) vs. risperidone 6 mg/day plus placebo (n = 23) | Psychopathology: PANSS (at baseline, weeks 2, 4, and 8) | Patients receiving the combination of risperidone and raloxifene 120 mg/day presented higher improvement in positive symptoms than placebo |
| Huerta-Ramos et al., 2014 [30] | 12-week double-blind randomized placebo-controlled trial | Raloxifene 60 mg/day (n = 16) vs. placebo (n = 17) | Psychopathology: PANSS (at baseline, week 12) Cognition: Neuropsychological battery (at baseline, week 12) |
Women receiving adjunctive raloxifene 60 mg/day presented improvement in memory and executive function |
| Labad et al., 2016 [33] | 24-week double-blind randomized parallel placebo-controlled trial | Raloxifene 60 mg/day (n = 36) vs. placebo | Psychopathology: PANSS (baseline, weeks 4, 12, and 24) Genetics: ESR1 and UGT1A8 gene |
Genetic variants in UGT1A8 and ESR1 genes modulated, respectively, response to raloxifene in terms of negative and general symptoms |
| Weiser et al., 2017 [35] | 16-week double-blind placebo-controlled RCT | Raloxifene 120 mg/day vs. placebo | Psychopathology: PANSS, CGI Cognition: Composite Brief Assessment of cognition |
Severely ill decompensated patients receiving antipsychotics plus raloxifene showed no significant improvement in psychopathology |
| Gurvich et al., 2019 [29] | Pooled data from two 12-weeks RCT | Raloxifene 120 mg/day (n = 33) vs. placebo (n = 36) | Psychopathology: PANSS, MADRS Cognition: RBANS |
When accounting for menopause status and hormone levels, women treated with raloxifene presented higher changes in cognitive performance compared to placebo |
| Brand et al., 2020 [28] | 12-week double-blind placebo-controlled, double-blind, RCT | Raloxifene 120 mg/day vs. placebo | Psychopathology: PANSS Cognition: BACS |
Study protocol (not finished): including men and pre/perimenopausal women |
Abbreviations: BACS, Brief Assessment of Cognition in Schizophrenia; CGI, Clinical Global Impression Scale; ESR1, Oestrogen Receptor 1; MADRS, Montgomery–Asberg Depression Rating Scale; PANSS, Positive and Negative Syndrome Scale; RBANS, Repeatable Battery for the Assessment of Neuropsychological Status; RCT, Randomized Clinical Trial; SANSS, Scale for the Assessment of Negative Symptoms; and UGT1A8, UDP-glucuronosyltransferase 1A8.