Safety and effectiveness of continuation antidepressant versus mood stabilizer monotherapy for relapse-prevention of bipolar II depression: A randomized, double-blind, parallel-group, prospective study.
Safety and effectiveness of continuation antidepressant versus mood stabilizer monotherapy for relapse-prevention of bipolar II depression: A randomized, double-blind, parallel-group, prospective study.
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DOI：
10.1016/j.jad.2015.05.070
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发表时间：
2015-10-01
影响因子：
6.6
通讯作者：
DeRubeis RJ
中科院分区：
文献类型：
--
作者：
Amsterdam JD;Lorenzo-Luaces L;Soeller I;Li SQ;Mao JJ;DeRubeis RJ
比较持续抗抑郁药和情绪稳定剂单一疗法预防双相II型抑郁症复发的安全性和有效性。受试者为≥，年龄18岁，患有双相II型抑郁症(n=12 9)，随机分为文拉法辛双盲组和锂盐单用组，疗程12周。抑郁评分≥下降50%的应答者继续接受另外6个月的预防复发单一治疗。主要结果是持续单一治疗期间抑郁复发。次要结果包括从治疗开始到研究终点的持续应答率、复发风险、复发时间、躁狂分级的变化，以及治疗出现的亚综合征低躁狂和/或抑郁发作的频率。文拉法辛的持续有效率高于锂(p<；0.0001)；然而，在持续单一治疗期间，文拉法辛和锂在复发率(7.5%)和锂(26.7%)、复发风险(p=0.073)或复发时间(p=0.090)方面没有差异。随着时间的推移，躁狂评分没有组间差异，症状或亚症状躁狂发作的频率或持续时间也没有差异。在锂单药治疗期间有更多的亚综合征抑郁发作(p=0.03)。样本量受到锂与文拉法新的持续应答率较低的限制；研究没有特别的动力来检测两组之间治疗后出现的躁狂或抑郁发作的差异。结果表明，持续的文拉法辛单一疗法可以提供与锂类似的预防效果，在治疗后出现的低躁狂发作方面没有差异，并且不需要频繁的血清锂水平和代谢监测。需要更大规模的前瞻性试验来证实这些观察结果。
Compare the safety and effectiveness of continuation antidepressant versus mood stabilizer monotherapy for preventing depressive relapse in bipolar II disorder. Subjects ≥18 years old with bipolar II depression (n=129) were randomized to double-blind venlafaxine or lithium monotherapy for 12 weeks. Responders with a ≥50% reduction in depression score were continued for an additional 6 months of relapse-prevention monotherapy. Primary outcome was depressive relapse during continuation monotherapy. Secondary outcomes included sustained response rate from initiation of treatment to study end-point, relapse hazard, time to relapse, change in mania ratings, and frequency of treatment-emergent sub-syndromal hypomania and/or depressive episodes. Venlafaxine produced greater sustained response rate versus lithium (p<0.0001); however, there was no difference in relapse rate for venlafaxine (7.5%) versus lithium (26.7%) (p=0.079); relapse hazard (p=0.073), or time to relapse (p=0.090) between treatment conditions during continuation monotherapy. There were no group differences in mania rating scores over time and no difference in frequency or duration of syndromal or sub-syndromal hypomanic episodes. There were more sub-syndromal depressive episodes during lithium monotherapy (p=0.03). Sample size was limited by the lower sustained response rate for lithium versus venlafaxine; study was not specifically powered to detect differences in treatment-emergent hypomanic or depressive episodes between groups. Results suggest that continuation venlafaxine monotherapy may provide similar prophylactic effectiveness relative to lithium, with no difference in treatment-emergent hypomanic episodes and without the need for frequent serum lithium level and metabolic monitoring. Larger, prospective trials are needed to confirm these observations.