Dept. of Psychiatry and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität, Dresden, Germany.
J Affect Disord. 2010 Nov;126(3):453-7. doi: 10.1016/j.jad.2010.04.025. Epub 2010 Jun 12.
To compare the efficacy and safety of adjunctive treatment with paroxetine or amitriptyline in patients with bipolar disorder who relapsed into a depressive episode during lithium maintenance therapy.
Data from a randomized, double-blind trial comparing paroxetine (N=18) or amitriptyline (N=22) as adjunctive treatment for an episode of depression during lithium maintenance therapy were reanalyzed. Only patients with a diagnosis of bipolar disorder were included. The primary endpoint was the change in Hamilton Rating Scale for Depression (HAM-D21) from randomization to study end (week 6).
There was a significant reduction of HAM-D21 total score from randomization to study end in both treatment groups. The mean change in HAM-D21 score in the paroxetine and amitriptyline groups at study end was -14.9 and -15.5 (p=0.798), and the mean HAM-D21 at study end was 8.2 vs. 9.9 (p=0.420), respectively. The patients treated with paroxetine showed a more rapid improvement with lower HAM-D21 scores between weeks 3 and 5. Tolerability was similar in both groups.
No placebo comparator group and relatively small study sample size.
Adjunctive treatment with either paroxetine or amitriptyline is a viable option for breakthrough depression during lithium maintenance therapy.
比较在锂盐维持治疗期间复发抑郁发作的双相障碍患者中，辅助应用帕罗西汀或阿米替林的疗效和安全性。
重新分析了一项比较帕罗西汀（N=18）或阿米替林（N=22）作为锂盐维持治疗期间抑郁发作辅助治疗的随机、双盲试验的数据。仅纳入双相障碍诊断患者。主要终点是汉密尔顿抑郁量表（HAM-D21）从随机分组到研究结束（第 6 周）的变化。
两组患者HAM-D21 总分均有显著下降。在研究结束时，帕罗西汀组和阿米替林组的 HAM-D21 评分变化均值分别为-14.9 和-15.5（p=0.798），研究结束时的 HAM-D21 均值分别为 8.2 和 9.9（p=0.420）。与阿米替林组相比，帕罗西汀组在第 3 至 5 周之间HAM-D21 评分下降更快，改善更明显。两组的耐受性相似。
无安慰剂对照组和研究样本量相对较小。
在锂盐维持治疗期间，辅助应用帕罗西汀或阿米替林治疗突破性抑郁是一种可行的选择。
