Venlafaxine versus lithium monotherapy of rapid and non-rapid cycling patients with bipolar II major depressive episode: A randomized, parallel group, open-label trial
Venlafaxine versus lithium monotherapy of rapid and non-rapid cycling patients with bipolar II major depressive episode: A randomized, parallel group, open-label trial
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DOI：
10.1016/j.jad.2008.03.029
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发表时间：
2009-01-01
影响因子：
6.6
通讯作者：
Shults, Justine
中科院分区：
文献类型：
--
作者：
Amsterdam, Jay D.;Wang, Chia-Hao;Shults, Justine
背景：治疗双相11型（BP 11）重度抑郁发作（MDE）患者的最佳初始治疗方法缺乏对照临床数据。在这项分析中，我们检查了短期文拉法辛与锂单药治疗在快速和非快速循环BP 11 MDE患者中的安全性和抗抑郁疗效。我们假设，在快速循环的BP 11 MDE患者中，锂的疗效优于文拉法辛，其症状和亚症状轻躁和混合性情绪转换较少。方法：患者随机接受文拉法辛37.5-375 mg /天或锂300-2100 mg /天的单药治疗，持续12周。主要结果测量是28项汉密尔顿抑郁评分（HAM-D - 28），嵌入“典型”HAM-D - 17和“非典型”HAM-D - 17- r症状评分。次要结果包括青年躁狂症评定量表（YMRS）、临床总体印象严重程度（CGI/S）和变化（CGI/C）评分、反应者比例（>=基线HAM-D评分降低50%）和缓解者比例（最终HAM-D评分=每年4次情感发作）。我们没有使用患者记录的每日时间记录来识别超短情绪转换。该研究采用随机、平行组、开放标签设计。结论：这些探索性分析的观察结果表明，对于快速和非快速循环的BP II型MDE患者，文拉法辛单药治疗可能比锂单药治疗更有效，且情绪转化率相似。这些数据支持先前的观察，文拉法辛单药治疗可能是有效的初始治疗BP II MDE。(C) 2008 Elsevier B.V.版权所有
Background: There is a paucity of controlled clinical data on the best initial therapy for treating patients with bipolar type 11 (BP 11) major depressive episode (MDE). In this analysis, we examined the safety and antidepressant efficacy of short-term venlafaxine versus lithium monotherapy in rapid and non-rapid cycling patients with BP 11 MDE. We hypothesized that lithium Would have superior efficacy to venlafaxine, with fewer syndromal and sub-syndromal hypomanic and mixed mood conversion, in the rapid cycling BP 11 MDE patients.Methods: Patients were randomized to monotherapy with either venlafaxine 37.5-375 mg daily or lithium 300-2100 mg daily for 12 weeks. The primary outcome measure was the 28-item Hamilton Depression Rating (HAM-D 28), with embedded 'typical' HAM-D 17 and 'atypical' HAM-D 17-R symptom scores. Secondary outcomes included the Young Mania Rating Scale (YMRS), clinical global impressions severity (CGI/S) and change (CGI/C) ratings, the proportion of responders (with >= 50% reduction in baseline HAM-D score) and remitters (with a final HAM-D score = 4 affective episodes per year). We did not employ a patient-recorded daily chrono-record to identify Ultra-short mood conversions. The Study used a randomized, parallel group, open-label design.Conclusion: These observations from this exploratory analysis suggest that venlafaxine monotherapy may be more effective than lithium monotherapy, with a similar mood conversion rate, in rapid and non-rapid cycling patients with BP II MDE. These data support prior observations that venlafaxine monotherapy may be effective initial treatment for BP II MDE. (C) 2008 Elsevier B.V. All rights reserved.