A double-blind, randomized, placebo-controlled trial of augmentation with lamotrigine or placebo in patients concomitantly treated with fluoxetine for resistant major depressive episodes
A double-blind, randomized, placebo-controlled trial of augmentation with lamotrigine or placebo in patients concomitantly treated with fluoxetine for resistant major depressive episodes
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DOI：
10.4088/jcp.v64n0407
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发表时间：
2003-04-01
影响因子：
5.3
通讯作者：
Vorster, M
中科院分区：
文献类型：
--
作者：
Barbosa, L;Berk, M;Vorster, M
背景资料：拉莫三嗪抗抑郁疗效的证据正在增加，尽管没有拉莫三嗪增强抑郁症的安慰剂对照试验。本研究的目的是评估，如果增强与拉莫三嗪是上级安慰剂的患者谁接受氟西汀为耐药的重性depression episodes.Method：23例患者谁经历了至少一个重性depression episode是耐至少一个抗抑郁治疗的前期试验被选中。这些患者接受氟西汀20 mg/天治疗，同时随机分配接受拉莫三嗪（N = 13）或安慰剂（N = 10）治疗6周。拉诺三嗪的剂量从25 mg/天上调至100 mg/天。入选了患有双相情感障碍（N = 8）或重度抑郁症（N = 15）（DSM-IV标准）的患者，导致样本异质性。主要的结果测量是汉密尔顿抑郁量表评分。结果：拉莫三嗪在终点时的临床总体耐受性量表绝对值均优于安慰剂，差异有统计学意义（上级）（平均SD临床总体印象-疾病严重程度评分：拉莫三嗪，2.15 ± 1.28;安慰剂，3.40 ± 1.17; p = 0.0308），并使用应答者分析，应答定义为临床疗效总评量表-改善评分为2或更低（拉莫三嗪，84.62% [N = 11];安慰剂，30.00% [N = 3]; p = 0.013）。拉莫三嗪对重度抑郁症和双相情感障碍患者的临床总体抑郁量表评分的影响。然而，拉莫三嗪在汉密尔顿抑郁量表和蒙哥马利-阿斯伯格抑郁量表上与安慰剂没有统计学差异。这种主要结局指标的差异化失败本质上是一个负面的研究结果。这一结果是最有可能使用的小样本量和由此产生的有限的权力的study.Conclusion：本试验的结果添加到文献中，提示潜在的疗效拉莫三嗪的抗抑郁药的配置文件的伪影。此外，这项研究指出了拉诺三嗪作为抑郁症增强剂的可能作用。
Background: Evidence of the antidepressant efficacy of lamotrigine is increasing, although there are no placebo-controlled trials of lamotrigine augmentation in depression. The aim of this study was to assess if augmentation with lamotrigine was superior to placebo in patients who were receiving fluoxetine for resistant major depressive episodes.Method: Twenty-three patients who had experienced at least I major depressive episode that was resistant to at least I prior trial of antidepressant therapy were selected. These patients were treated with fluoxetine, 20 mg/day, and concomitantly randomly assigned to receive either lamotrigine (N = 13) or placebo (N = 10) for 6 weeks. The dose of larnotrigine was titrated upward from 25 mg/day to 100 mg/day. Patients suffering from bipolar 11 disorder (N = 8) or from major depressive disorder (N = 15) (DSM-IV criteria) were enrolled, resulting in heterogeneity of the sample. The primary, outcome measure was Hamilton Rating Scale for Depression score. Data were collected from 2000-2001.Results: Lamotrigine was statistically superior to placebo on the Clinical Global Impressions scale at endpoint, both in absolute terms (mean SD Clinical Global Impressions-Severity of Illness scores: lamotrigine, 2.15 +/- 1.28; placebo, 3.40 +/- 1.17; p = .0308) and using a responder analysis, with response defined as a Clinical Global Impressions-Improvement score of 2 or less (lamotrigine, 84.62% [N = 11]; placebo, 30.00% [N = 3]; p, = .013). The effect of lamotrigine on Clinical Global Impressions scale scores was seen in both major depressive disorder and bipolar 11 disorder. Lamotrigine, however, failed to separate statistically from placebo on the Hamilton Rating Scale for Depression and Montgomery-Asberg Depression Rating Scale. This failure to differentiate on a primary outcome measure is essentially a negative study result. This result is most likely an artifact of the small sample size used and the resultant limited power of the study.Conclusion: The results of this trial add to the literature suggesting potential efficacy of the antidepressant profile of lamotrigine. In addition, this study points to a possible role of larnotrigine as an augmentation agent in depression.