Citalopram for Acute and Preventive Efficacy in Bipolar Depression (CAPE-BD): A Randomized, Double-Blind, Placebo-Controlled Trial
Citalopram for Acute and Preventive Efficacy in Bipolar Depression (CAPE-BD): A Randomized, Double-Blind, Placebo-Controlled Trial
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DOI：
10.4088/jcp.19m13136
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发表时间：
2021-01-01
影响因子：
5.3
通讯作者：
Patkar, Ashwin A.
中科院分区：
文献类型：
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作者：
Ghaemi, S. Nassir;Whitham, Elizabeth A.;Patkar, Ashwin A.
目的：通过一项随机、双盲、安慰剂对照试验，评价西酞普兰在双相抑郁症急性期和维持期的疗效和安全性。方法：在2007年至2014年期间，119名诊断为DSM-IV双相情感障碍（I型或II型）的急性重度抑郁发作患者随机随机服用西酞普兰或安慰剂，并添加标准情绪稳定剂。采用蒙哥马利-阿斯伯格抑郁评定量表（MADRS）和情感障碍与精神分裂症量表躁狂症评定量表（MRS-SADS）的评分对患者进行为期6周的急性疗效（主要结局）和长达1年的维持疗效（次要结局）随访。该研究获得了具有临床意义的效应值。结果：西酞普兰急性期结束时，平均+/- SD MADRS评分从基线值27.4 +/- 9.1变化到13.1 +/- 8.4，而安慰剂从27.4 +/- 7.3变化到15.2 +/- 9.9，临床和统计学差异无统计学意义。西酞普兰的维持疗效也不优于安慰剂。两组患者的急性躁狂/轻躁发作相似，II型患者的预后并不比I型患者好。在维持治疗中，西酞普兰与安慰剂相比，MRS-SADS评分总体上更高，特别是在病程快速循环的受试者中。结论：与安慰剂相比，加入标准情绪稳定剂的西酞普兰对双相抑郁症的急性或维持治疗没有临床意义上的益处。西酞普兰并未使急性躁狂加重，但维持治疗导致躁狂症状加重，特别是在快速循环病程的受试者中。
Objective: To assess the efficacy and safety of citalopram in the acute and maintenance phases of bipolar depression in a randomized, double-blind, placebo-controlled trial.Methods: Between 2007 and 2014, 119 subjects with acute major depressive episodes diagnosed with DSM-IV bipolar disorder, type I or type II, were randomized blindly to citalopram or placebo, added to standard mood stabilizers. They were followed for 6 weeks for acute efficacy (primary outcome) and up to 1 year for maintenance efficacy (secondary outcome) using scores on the Montgomery-Asberg Depression Rating Scale (MADRS) and the Mania Rating Scale of the Schedule for Affective Disorders and Schizophrenia (MRS-SADS). The study was powered for a clinically meaningful effect size.Results: Mean +/- SD MADRS scores changed from a baseline value of 27.4 +/- 9.1 to 13.1 +/- 8.4 at the end of the acute phase for citalopram versus a change from 27.4 +/- 7.3 to 15.2 +/- 9.9 for placebo, a clinically and statistically nonsignificant difference. Maintenance efficacy also was not better with citalopram than with placebo. Acute manic/hypomanic episodes were similar in both groups, and subjects with type II illness did not have better outcomes than subjects with type I illness. In maintenance treatment, MRS-SADS scores were greater overall, especially in subjects with a rapid-cycling illness course, with citalopram versus placebo.Conclusions: Citalopram, added to standard mood stabilizers, did not have clinically meaningful benefit versus placebo for either acute or maintenance treatment of bipolar depression. Acute mania did not worsen with citalopram, but maintenance treatment led to worsened manic symptoms, especially in subjects with a rapid-cycling course.