A placebo-controlled 18-month trial of lamotrigine and lithium maintenance treatment in recently manic or hypomanic patients with bipolar I disorder
A placebo-controlled 18-month trial of lamotrigine and lithium maintenance treatment in recently manic or hypomanic patients with bipolar I disorder
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DOI：
10.1001/archpsyc.60.4.392
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发表时间：
2003-04-01
影响因子：
--
通讯作者：
DeVeaugh-Geiss, J
中科院分区：
文献类型：
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作者：
Bowden, CL;Calabrese, JR;DeVeaugh-Geiss, J
背景：安慰剂对照临床试验显示拉莫三嗪是治疗双相抑郁和快速循环的有效药物。这项双盲、安慰剂对照研究旨在评估拉莫三嗪和锂剂与安慰剂相比预防近期躁狂或轻躁狂I型双相情感障碍患者情绪发作复发或再发的疗效和耐受性。经过8至16周的开放标签阶段，在此期间开始使用拉莫三嗪治疗，并停止其他精神药物治疗方案，患者随机接受拉莫三嗪治疗（每日100-400 mg），锂（0.8-1.1 mEq/L），或安慰剂作为双盲维持治疗长达18个月。在349名符合筛选标准并进入开放期的患者中，175例患者符合稳定标准，并随机接受双盲维持治疗（拉莫三嗪，59例患者;锂，46例患者;安慰剂，70例患者）。拉莫三嗪和锂剂在延长任何情绪发作的干预时间方面均上级安慰剂（拉莫三嗪vs安慰剂，P = .02;锂剂vs安慰剂，P = .006）。拉莫三嗪在延长抑郁发作时间方面上级安慰剂（P = 0.02）。锂剂在延长躁狂、轻躁狂或混合发作时间方面上级安慰剂（P = 0.006）。拉莫三嗪报告的最常见的不良事件是headach.Conclusions：拉莫三嗪和锂上级安慰剂预防复发或复发的情绪发作的患者最近经历了躁狂或轻躁狂发作的双相I型障碍。结果表明，拉莫三嗪是一种有效的，耐受性良好的维持治疗双相情感障碍，特别是预防抑郁症。
Background: Lamotrigine has been shown to be an effective treatment for bipolar depression and rapid cycling in placebo-controlled clinical trials. This double-blind, placebo-controlled study was conducted to assess the efficacy and tolerability of lamotrigine and lithium compared with placebo for the prevention of relapse or recurrence of mood episodes in recently manic or hypomanic patients with bipolar I disorder.Methods: After an 8- to 16-week open-label phase during which treatment with lamotrigine was initiated and other psychotropic drug regimens were discontinued, patients were randomized to lamotrigine (100-400 mg daily), lithium (0.8-1.1 mEq/L), or placebo as double-blind maintenance treatment for as long as 18 months.Results: Of 349 patients who met screening criteria and entered the open-label phase, 175 met stabilization criteria and were randomized to double-blind maintenance treatment (lamotrigine, 59 patients; lithium, 46 patients; and placebo, 70 patients). Both lamotrigine and lithium were superior to placebo at prolonging the time to intervention for any mood episode (lamotrigine vs placebo, P = .02; lithium vs placebo, P = .006). Lamotrigine was superior to placebo at prolonging the time to a depressive episode (P = .02). Lithium was superior to placebo at prolonging the time to a manic, hypomanic, or mixed episode (P = .006). The most common adverse event reported for lamotrigine was headache.Conclusions: Both lamotrigine and lithium were superior to placebo for the prevention of relapse or recurrence of mood episodes in patients with bipolar I disorder who had recently experienced a manic or hypomanic episode. The results indicate that lamotrigine is an effective, well-tolerated maintenance treatment for bipolar disorder, particularly for prophylaxis of depression.