Efficacy and safety of long-term fluoxetine versus lithium monotherapy of bipolar II disorder: a randomized, double-blind, placebo-substitution study.
Efficacy and safety of long-term fluoxetine versus lithium monotherapy of bipolar II disorder: a randomized, double-blind, placebo-substitution study.
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DOI：
10.1176/appi.ajp.2009.09020284
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发表时间：
2010-07
期刊：
影响因子：
--
通讯作者：
Shults J
中科院分区：
文献类型：
--
作者：
Amsterdam JD;Shults J
作者检查了长期氟西汀单药治疗、锂单药治疗和安慰剂治疗在预防双相II型重度抑郁症复发和复发方面的安全性和有效性。作者假设氟西汀单药治疗优于锂单药治疗，具有相似的轻躁情绪转换率。在最初的开放标签氟西汀单药治疗中从重度抑郁发作中恢复的至少18岁的患者被随机分配接受50周的双盲单药治疗，氟西汀10 - 40mg /天，锂300 - 1200mg /天，或安慰剂。主要观察指标为复发或复发时间。次要结果测量包括患者保持良好的比例和轻度躁狂症状的频率。氟西汀组（N=28）、锂组（N=26）和安慰剂组（N=27）的临床或人口学特征无显著差异。氟西汀组的平均复发时间为249.9天，锂组为156.4天，安慰剂组为186.9天。与锂相比，氟西汀的复发风险显著降低，锂的复发风险估计是氟西汀的2.5倍。治疗组之间在轻度躁狂症状方面没有统计学意义或临床意义的差异。一名服用氟西汀的患者和一名服用安慰剂的患者因轻度躁狂而停止治疗。这些发现表明，相对于锂单药治疗，长期氟西汀单药治疗可能在双相II型重度抑郁发作恢复后提供更好的复发预防益处，而不会增加轻躁情绪转换发作。
The authors examined the safety and efficacy of long-term fluoxetine monotherapy, lithium monotherapy, and placebo therapy in preventing relapse and recurrence of bipolar type II major depressive episode. The authors hypothesized that fluoxetine monotherapy would be superior to lithium monotherapy with a similar hypomanic mood conversion rate. Patients at least 18 years old who recovered from their major depressive episode during initial open-label fluoxetine monotherapy were randomly assigned to receive 50 weeks of double-blind monotherapy with fluoxetine at 10–40 mg/day, lithium at 300–1200 mg/day, or placebo. The primary outcome measure was time to relapse or recurrence. Secondary outcome measures included the proportion of patients remaining well and the frequency of hypomanic symptoms. There were no significant differences in clinical or demographic characteristics among the fluoxetine (N=28), lithium (N=26), and placebo (N=27) groups. The mean time to relapse was 249.9 days for the fluoxetine group, 156.4 days for the lithium group, and 186.9 days for the placebo group. The hazard of relapse was significantly lower with fluoxetine compared with lithium, and the estimated hazard of relapse with lithium was 2.5 times greater than with fluoxetine. There were no statistically significant or clinically meaningful differences in hypomanic symptoms among treatment groups over time. One patient taking fluoxetine and one patient taking placebo discontinued treatment because of hypomania. These findings suggest that long-term fluoxetine monotherapy may provide superior relapse-prevention benefit relative to lithium monotherapy after recovery from bipolar II major depressive episode without an increase in hypomanic mood conversion episodes.
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影响因子：
5.4
作者：
Amsterdam, JD;Shults, J;Hundert, M
通讯作者：
Hundert, M
影响因子：
5.3
作者：
Ghaemi, SN;Boiman, EE;Goodwin, FK
通讯作者：
Goodwin, FK
影响因子：
5.3
作者：
Ghaemi, SN;Lenox, MS;Baldessarini, RJ
通讯作者：
Baldessarini, RJ
影响因子：
10.5
作者：
Michelson, D;Fava, M;Tepner, RG
通讯作者：
Tepner, RG
影响因子：
6.6
作者：
Amsterdam, Jay D.;Wang, Chia-Hao;Shults, Justine
通讯作者：
Shults, Justine