PS39. Prescription Patterns for Bipolar Disorders in a Psychiatric Hospital in Japan
نویسندگان
چکیده
s | 13 Abstract Objective: The aim of this post-hoc analysis was to evaluate the effect of depression severity on clinical response in patients with bipolar depression treated with lurasidone. Methods: Patients with bipolar I depression in 2 registration trials were randomized to 6 weeks of once-daily, double-blind, placebo-controlled treatment with lurasidone monotherapy (20–60 mg/d or 80–120 mg/d; N=499); or with lurasidone adjunctive to lithium or valproate (20–120 mg/d; N=345). Two baseline depression severity groups were defined post-hoc: a moderate (Montgomery-Asberg Depression Rating Scale [MADRS] total score: 20–29) and a high (MADRS≥30) severity group. For each group, changes in MADRS total score were analyzed using a mixed model for repeated measures analysis. Results: In the monotherapy study, 42.9% of patients were in the moderate severity group (mean MADRS total score: 26.0) and 57.1% were in the high severity group (MADRS: 33.9). In the adjunctive therapy study, 39.7% of patients were in the moderate severity group (mean MADRS: 25.7) and 60.3% were in the high severity group (MADRS: 34.0). In the monotherapy study, lurasidone vs. placebo effect sizes (Cohen’s d) for MADRS change at week 6 in the high severity vs. moderate severity groups were d=0.60 (P<0.001) vs. 0.40 (P=0.035) for the 20–60 mg/d dose range, and d=0.55 (P=0.002) vs. 0.50 (P=0.008) for the 80–120 mg/d dose range; and in the adjunctive therapy study, effect sizes for MADRS change in the high severity vs. moderate severity groups were d=0.25 (P=0.10) vs. d=0.41 (P=0.033). A treatment by baseline severity interaction test was non-significant for both the monotherapy and adjunctive therapy studies. Conclusions: In this post-hoc analysis, the magnitude of endpoint improvement in depressive symptoms vs. placebo was comparable for patients with both moderate and high levels of baseline depression severity during for both monotherapy and adjunctive therapy with lurasidone.Objective: The aim of this post-hoc analysis was to evaluate the effect of depression severity on clinical response in patients with bipolar depression treated with lurasidone. Methods: Patients with bipolar I depression in 2 registration trials were randomized to 6 weeks of once-daily, double-blind, placebo-controlled treatment with lurasidone monotherapy (20–60 mg/d or 80–120 mg/d; N=499); or with lurasidone adjunctive to lithium or valproate (20–120 mg/d; N=345). Two baseline depression severity groups were defined post-hoc: a moderate (Montgomery-Asberg Depression Rating Scale [MADRS] total score: 20–29) and a high (MADRS≥30) severity group. For each group, changes in MADRS total score were analyzed using a mixed model for repeated measures analysis. Results: In the monotherapy study, 42.9% of patients were in the moderate severity group (mean MADRS total score: 26.0) and 57.1% were in the high severity group (MADRS: 33.9). In the adjunctive therapy study, 39.7% of patients were in the moderate severity group (mean MADRS: 25.7) and 60.3% were in the high severity group (MADRS: 34.0). In the monotherapy study, lurasidone vs. placebo effect sizes (Cohen’s d) for MADRS change at week 6 in the high severity vs. moderate severity groups were d=0.60 (P<0.001) vs. 0.40 (P=0.035) for the 20–60 mg/d dose range, and d=0.55 (P=0.002) vs. 0.50 (P=0.008) for the 80–120 mg/d dose range; and in the adjunctive therapy study, effect sizes for MADRS change in the high severity vs. moderate severity groups were d=0.25 (P=0.10) vs. d=0.41 (P=0.033). A treatment by baseline severity interaction test was non-significant for both the monotherapy and adjunctive therapy studies. Conclusions: In this post-hoc analysis, the magnitude of endpoint improvement in depressive symptoms vs. placebo was comparable for patients with both moderate and high levels of baseline depression severity during for both monotherapy and adjunctive therapy with lurasidone. Sponsored by Sunovion Pharmaceuticals Inc. PS38 Psychotropic medication for bipolar patients in the psychiatric acute inpatient unit. Hiroki Sasamori, Hiroki Yamada, Akira Yoshizawa, Kouichi Jinbo, Sachiko Yokoyama, Yuzuru Ishibe, Teppei Morita, Osamu Takashio,
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عنوان ژورنال:
دوره 19 شماره
صفحات -
تاریخ انتشار 2016