A Placebo-Controlled Study of Raloxifene Added to Risperidone in Men with Chronic Schizophrenia
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 adjuv...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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Tehran University of Medical Sciences
2015-06-01
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| Series: | Acta Medica Iranica |
| Subjects: | |
| Online Access: | https://acta.tums.ac.ir/index.php/acta/article/view/4880 |
| _version_ | 1830453186329051136 |
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| author | Mohammad-Reza Khodaie-Ardakani Mohsen Khosravi Razieh Zarinfard Somayeh Nejati Ali Mohsenian Mina Tabrizi Shahin Akhondzadeh |
| author_facet | Mohammad-Reza Khodaie-Ardakani Mohsen Khosravi Razieh Zarinfard Somayeh Nejati Ali Mohsenian Mina Tabrizi Shahin Akhondzadeh |
| author_sort | Mohammad-Reza Khodaie-Ardakani |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-21T09:02:38Z |
| format | Article |
| id | doaj.art-560812c8897d4d2d91007eafb587c644 |
| institution | Directory Open Access Journal |
| issn | 0044-6025 1735-9694 |
| language | English |
| last_indexed | 2024-12-21T09:02:38Z |
| publishDate | 2015-06-01 |
| publisher | Tehran University of Medical Sciences |
| record_format | Article |
| series | Acta Medica Iranica |
| spelling | doaj.art-560812c8897d4d2d91007eafb587c6442022-12-21T19:09:26ZengTehran University of Medical SciencesActa Medica Iranica0044-60251735-96942015-06-015364833A Placebo-Controlled Study of Raloxifene Added to Risperidone in Men with Chronic SchizophreniaMohammad-Reza Khodaie-Ardakani0Mohsen Khosravi1Razieh Zarinfard2Somayeh Nejati3Ali Mohsenian4Mina Tabrizi5Shahin Akhondzadeh6Razi Hospital, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.Razi Hospital, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.Razi Hospital, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.Department of Medical Genetics, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.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.https://acta.tums.ac.ir/index.php/acta/article/view/4880EstrogenRaloxifeneSchizophreniaMen |
| spellingShingle | Mohammad-Reza Khodaie-Ardakani Mohsen Khosravi Razieh Zarinfard Somayeh Nejati Ali Mohsenian Mina Tabrizi Shahin Akhondzadeh A Placebo-Controlled Study of Raloxifene Added to Risperidone in Men with Chronic Schizophrenia Acta Medica Iranica Estrogen Raloxifene Schizophrenia Men |
| title | A Placebo-Controlled Study of Raloxifene Added to Risperidone in Men with Chronic Schizophrenia |
| title_full | A Placebo-Controlled Study of Raloxifene Added to Risperidone in Men with Chronic Schizophrenia |
| title_fullStr | A Placebo-Controlled Study of Raloxifene Added to Risperidone in Men with Chronic Schizophrenia |
| title_full_unstemmed | A Placebo-Controlled Study of Raloxifene Added to Risperidone in Men with Chronic Schizophrenia |
| title_short | A Placebo-Controlled Study of Raloxifene Added to Risperidone in Men with Chronic Schizophrenia |
| title_sort | placebo controlled study of raloxifene added to risperidone in men with chronic schizophrenia |
| topic | Estrogen Raloxifene Schizophrenia Men |
| url | https://acta.tums.ac.ir/index.php/acta/article/view/4880 |
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