Kotaro Hatta1, Taro Otachi2, Kiyoshi Fujita3, Fumiyoshi Morikawa4, Shin Ito5, Hirofumi Tomiyama6, Takayuki Abe7, Yasuhiko Sudo8, Hiroshi Takebayashi9, Toru Yamashita10, Shigemasa Katayama11, Reiko Nakase12, Yutaka Shirai13, Chie Usui14, Hiroyuki Nakamura15, Hiroto Ito16, Toyoaki Hirata7, Yutaka Sawa17. 1. Department of Psychiatry, Juntendo University Nerima Hospital, Tokyo, Japan; Department of Social Psychiatry, National Center of Neurology and Psychiatry, Kodaira, Japan. Electronic address: khatta@juntendo.ac.jp. 2. Department of Psychiatry, Gunma Psychiatric Medical Center, Isezaki, Japan. 3. Department of Psychiatry, The Okehazama Hospital, Toyoake, Japan. 4. Department of Psychiatry, Asahikawa Keisenkai Hospital, Asahikawa, Japan. 5. Department of Psychiatry, Kumpukai Yamada Hospital, Tokyo, Japan. 6. Department of Psychiatry, National Hospital Organization Hizen Psychiatric Center, Yoshinogari, Japan. 7. Department of Psychiatry, Chiba Psychiatric Medical Center, Chiba, Japan. 8. Department of Psychiatry, Tosa Hospital, Kochi, Japan. 9. Department of Psychiatry, Saitama Prefectural Psychiatric Hospital, Ina-machi, Japan. 10. Department of Psychiatry, Yamanashi Prefectural Kita Hospital, Nirasaki, Japan. 11. Department of Psychiatry, Seijin Hospital, Tokyo, Japan. 12. Department of Psychiatry, Mie Prefectural Mental Medical Center, Tsu, Japan. 13. Department of Psychiatry, Hyogo Prefecture Kofu Hospital, Kobe, Japan. 14. Department of Psychiatry, Juntendo University Nerima Hospital, Tokyo, Japan. 15. Department of Environmental and Preventive Medicine, Kanazawa University Graduate School of Medical Science, Kanazawa, Japan. 16. Department of Social Psychiatry, National Center of Neurology and Psychiatry, Kodaira, Japan. 17. Department of Psychiatry, Sawa Hospital, Osaka, Japan.
Abstract
PURPOSE: We examined whether augmentation with olanzapine would be superior to switching to olanzapine among early non-responders (ENRs) to risperidone, and whether augmentation with risperidone would be superior to switching to risperidone among ENRs to olanzapine. We performed a rater-blinded, randomized clinical trial at psychiatric emergency sites. Eligible patients were newly admitted patients with acute schizophrenia. ENRs to the initial antipsychotic (Clinical Global Impressions-Improvement Scale: ≥ 4 at 2 weeks) were allocated to receive either augmentation with or switching to the other antipsychotic (RIS+OLZ vs. RIS-OLZ; OLZ+RIS vs. OLZ-RIS) RESULTS:Sixty patients who completed 2 weeks ofrisperidone treatment were divided into 33 early responders (RIS-ER) and 27 ENRs (RIS+OLZ, n=14; RIS-OLZ, n=13). Although time to treatment discontinuation for any cause was significantly shorter in RIS+OLZ group (54.1 days [95% confidence interval, 41.3-67.0]) than in RIS-ER group (68.7 [61.2-76.2]; P=0.050), it was not significantly shorter in RIS-OLZ group (58.5 [43.1-73.9]) than in RIS-ER group (P=0.19). Sixty patients who completed 2 weeks ofolanzapine treatment were divided into 36 early responders (OLZ-ER) and 24 ENRs (OLZ+RIS, n=11; OLZ-RIS, n=13). Although time to treatment discontinuation for any cause was significantly shorter in OLZ-RIS group (56.1days [40.7-71.5]) than in OLZ-ER group (74.9 [68.5-81.3]; P=0.008), it was not significantly shorter in OLZ+RIS group (64.6 [49.6-79.6]) than in OLZ-ER group (P=0.20). CONCLUSION: Despite the lack of pharmacokinetic investigation of dose adequacy in this study, it is possible that switching to olanzapine among ENRs to risperidone might have a small advantage over augmentation with olanzapine, while augmentation with risperidone might have a small advantage over switching to risperidone among ENRs to olanzapine. Further research is required before it would be appropriate to modify routine practice in the direction of these findings.
RCT Entities:
PURPOSE: We examined whether augmentation with olanzapine would be superior to switching to olanzapine among early non-responders (ENRs) to risperidone, and whether augmentation with risperidone would be superior to switching to risperidone among ENRs to olanzapine. We performed a rater-blinded, randomized clinical trial at psychiatric emergency sites. Eligible patients were newly admitted patients with acute schizophrenia. ENRs to the initial antipsychotic (Clinical Global Impressions-Improvement Scale: ≥ 4 at 2 weeks) were allocated to receive either augmentation with or switching to the other antipsychotic (RIS+OLZ vs. RIS-OLZ; OLZ+RIS vs. OLZ-RIS) RESULTS: Sixty patients who completed 2 weeks of risperidone treatment were divided into 33 early responders (RIS-ER) and 27 ENRs (RIS+OLZ, n=14; RIS-OLZ, n=13). Although time to treatment discontinuation for any cause was significantly shorter in RIS+OLZ group (54.1 days [95% confidence interval, 41.3-67.0]) than in RIS-ER group (68.7 [61.2-76.2]; P=0.050), it was not significantly shorter in RIS-OLZ group (58.5 [43.1-73.9]) than in RIS-ER group (P=0.19). Sixty patients who completed 2 weeks of olanzapine treatment were divided into 36 early responders (OLZ-ER) and 24 ENRs (OLZ+RIS, n=11; OLZ-RIS, n=13). Although time to treatment discontinuation for any cause was significantly shorter in OLZ-RIS group (56.1days [40.7-71.5]) than in OLZ-ER group (74.9 [68.5-81.3]; P=0.008), it was not significantly shorter in OLZ+RIS group (64.6 [49.6-79.6]) than in OLZ-ER group (P=0.20). CONCLUSION: Despite the lack of pharmacokinetic investigation of dose adequacy in this study, it is possible that switching to olanzapine among ENRs to risperidone might have a small advantage over augmentation with olanzapine, while augmentation with risperidone might have a small advantage over switching to risperidone among ENRs to olanzapine. Further research is required before it would be appropriate to modify routine practice in the direction of these findings.
Authors: Luis Molina; Byron Recinos; Bezner Paz; Mauricio Rovelo; Fanny Elizabeth Elias Rodriguez; José Calderón; Arturo Arellano; Santiago Pomata; María Verónica Rey; Santiago Perez-Lloret Journal: Clin Drug Investig Date: 2016-06 Impact factor: 2.859
Authors: Stefan Leucht; Inge Winter-van Rossum; Stephan Heres; Celso Arango; W Wolfgang Fleischhacker; Birte Glenthøj; Marion Leboyer; F Markus Leweke; Shôn Lewis; Phillip McGuire; Andreas Meyer-Lindenberg; Dan Rujescu; Shitij Kapur; René S Kahn; Iris E Sommer Journal: Schizophr Bull Date: 2015-03-18 Impact factor: 9.306