Nasrallah Henry A, Cucchiaro Josephine B, Mao Yongcai, Pikalov Andrei A, Loebel Antony D
1Department of Neurology and Psychiatry,St. Louis University,St. Louis,Missouri,USA.
2Sunovion Pharmaceuticals Inc.,Fort Lee,New Jersey,USA.
CNS Spectr. 2015 Apr;20(2):140-7. doi: 10.1017/S1092852914000285. Epub 2014 Jun 23.
Depressive symptoms are common in schizophrenia and can worsen outcomes and increase suicide risk. Lurasidone is an atypical antipsychotic agent indicated for the treatment of schizophrenia and for the treatment of major depressive episodes associated with bipolar I disorder. This post hoc analysis evaluated the effect of lurasidone on depressive symptoms in patients with schizophrenia.
Patient-level data were pooled from 4 similarly designed, double-blind, placebo-controlled, 6-week registration studies of lurasidone (40-160 mg/d) in adult patients with an acute exacerbation of schizophrenia. Changes in depressive symptoms, measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), were analyzed for the overall sample and for subgroups of patients stratified by baseline MADRS scores.
MADRS assessments at baseline and endpoint (day 42 or last observation carried forward [LOCF]) were available for 1330 patients. Patients receiving lurasidone experienced significantly greater decreases in MADRS score (-2.8, least-squares [LS] mean change, LOCF) compared with patients receiving placebo (-1.4, P < .001, effect size 0.24). Analysis of change in MADRS score (LOCF) by baseline symptom severity (MADRS score of ≥12, ≥14, ≥16, ≥18) showed significantly greater improvement for lurasidone-treated patients across all severity groups; effect sizes ranged from 0.25 to 0.34. Among patients with a baseline MADRS score of ≥12, depressive symptom remission (defined as MADRS score <10 at LOCF endpoint) was attained by 45.0% of lurasidone-treated patients and 36.3% of patients receiving placebo (P < .05).
In a pooled analysis of short-term, placebo-controlled studies, lurasidone significantly improved depressive symptoms in patients with schizophrenia.
抑郁症状在精神分裂症中很常见，会使病情恶化并增加自杀风险。鲁拉西酮是一种非典型抗精神病药物，用于治疗精神分裂症以及与双相I型障碍相关的重度抑郁发作。这项事后分析评估了鲁拉西酮对精神分裂症患者抑郁症状的影响。
患者水平的数据来自4项设计相似、双盲、安慰剂对照、为期6周的鲁拉西酮（40 - 160 mg/天）用于成年精神分裂症急性加重患者的注册研究。采用蒙哥马利-Åsberg抑郁评定量表（MADRS）测量抑郁症状的变化，对总体样本以及按基线MADRS评分分层的患者亚组进行分析。
1330例患者有基线和终点（第42天或末次观察结转[LOCF]）时的MADRS评估数据。与接受安慰剂的患者相比，接受鲁拉西酮治疗的患者MADRS评分显著降低更多（-2.8，最小二乘[LS]均值变化，LOCF）（-1.4，P <.001，效应大小0.24）。根据基线症状严重程度（MADRS评分≥12、≥14、≥16、≥18）对MADRS评分（LOCF）变化进行分析，结果显示在所有严重程度组中，鲁拉西酮治疗的患者改善更为显著；效应大小范围为0.25至0.34。在基线MADRS评分≥12的患者中，45.0%接受鲁拉西酮治疗的患者和36.3%接受安慰剂治疗的患者实现了抑郁症状缓解（定义为LOCF终点时MADRS评分<10）（P <.05）。
在短期、安慰剂对照研究的汇总分析中，鲁拉西酮显著改善了精神分裂症患者的抑郁症状。
