Sanford Mark, Dhillon Sohita
Springer, Private Bag 65901, Mairangi Bay 0754, Auckland, New Zealand,
CNS Drugs. 2015 Mar;29(3):253-63. doi: 10.1007/s40263-015-0234-2.
Lurasidone (Latuda(®)), a benzisothiazole derivative antipsychotic, is approved in the USA and Canada for the treatment of adults with major depressive episodes (MDE) associated with bipolar I disorder; this article reviews studies of lurasidone in this indication. In two 6-week, placebo-controlled trials in adults with bipolar I depression, lurasidone 20-120 mg/day reduced depressive symptoms, either as monotherapy or as an adjunct to lithium or valproate. Lurasidone reduced the mean Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline (primary endpoint) by >50 %; the reductions in scores were significantly greater than with placebo. The treatment effects were small to medium and the numbers needed to treat to obtain an additional MDE response (≥50 % reduction from baseline in the MADRS total score) were ≤7 across the lurasidone groups. In a third, similarly designed trial of lurasidone 20-120 mg/day adjunctive to lithium or valproate, there was no significant between-group difference in the change in the mean MADRS total score at week 6 (primary endpoint), although significant differences favouring lurasidone were observed from week 2 to week 5. Across trials, the most frequently occurring adverse events included akathisia, extrapyramidal symptoms and somnolence. Lurasidone had a favourable profile with respect to weight gain and metabolic disturbances, known to occur with some other antipsychotics. Thus, lurasidone offers a valuable addition to the therapies available for adult patients with bipolar depression, either as monotherapy or as an adjunct to lithium or valproate.
鲁拉西酮（Latuda(®)）是一种苯并异噻唑衍生物类抗精神病药物，在美国和加拿大被批准用于治疗伴有双相I型障碍的成人重度抑郁发作（MDE）；本文回顾了鲁拉西酮在这一适应症方面的研究。在两项针对双相I型抑郁症成人患者的为期6周的安慰剂对照试验中，鲁拉西酮20 - 120毫克/天可减轻抑郁症状，无论是作为单一疗法还是作为锂盐或丙戊酸盐的辅助治疗。鲁拉西酮使蒙哥马利 - 阿斯伯格抑郁评定量表（MADRS）总分从基线水平（主要终点）降低了>50%；得分降低幅度显著大于安慰剂组。治疗效果为小到中等，在各鲁拉西酮组中，为获得额外的MDE反应（MADRS总分从基线水平降低≥50%）所需治疗的人数≤7。在第三项设计类似的试验中，鲁拉西酮20 - 120毫克/天作为锂盐或丙戊酸盐的辅助治疗，在第6周（主要终点）时，组间平均MADRS总分变化无显著差异，不过在第2周至第5周观察到有利于鲁拉西酮的显著差异。在各项试验中，最常出现的不良事件包括静坐不能、锥体外系症状和嗜睡。鲁拉西酮在体重增加和代谢紊乱方面表现良好，而这是一些其他抗精神病药物已知会出现的情况。因此，鲁拉西酮为双相抑郁症成年患者的现有治疗方法增添了一种有价值的选择，无论是作为单一疗法还是作为锂盐或丙戊酸盐的辅助治疗。
