Calabrese J R, Bowden C L, Sachs G S, Ascher J A, Monaghan E, Rudd G D
Case Western Reserve University, Cleveland, Ohio, USA.
J Clin Psychiatry. 1999 Feb;60(2):79-88. doi: 10.4088/jcp.v60n0203.
More treatment options for bipolar depression are needed. Currently available antidepressants may increase the risk of mania and rapid cycling, and mood stabilizers appear to be less effective in treating depression than mania. Preliminary data suggest that lamotrigine, an established antiepileptic drug, may be effective for both the depression and mania associated with bipolar disorder. This is the first controlled multicenter study evaluating lamotrigine monotherapy in the treatment of bipolar I depression.
Outpatients with bipolar I disorder experiencing a major depressive episode (DSM-IV, N = 195) received lamotrigine (50 or 200 mg/day) or placebo as monotherapy for 7 weeks. Psychiatric evaluations, including the Hamilton Rating Scale for Depression (HAM-D), the Montgomery-Asberg Depression Rating Scale (MADRS), Mania Rating Scale, and the Clinical Global Impressions scale for Severity (CGI-S) and Improvement (CGI-I) were completed at each weekly visit.
Lamotrigine 200 mg/day demonstrated significant antidepressant efficacy on the 17-item HAM-D, HAM-D Item 1, MADRS, CGI-S, and CGI-I compared with placebo. Improvements were seen as early as week 3. Lamotrigine 50 mg/day also demonstrated efficacy compared with placebo on several measures. The proportions of patients exhibiting a response on CGI-I were 51%, 41%, and 26% for lamotrigine 200 mg/day, lamotrigine 50 mg/day, and placebo groups, respectively. Adverse events and other safety results were similar across treatment groups, except for a higher rate of headache in the lamotrigine groups.
Lamotrigine monotherapy is an effective and well-tolerated treatment for bipolar depression.
双相抑郁需要更多的治疗选择。目前可用的抗抑郁药可能会增加躁狂和快速循环的风险，而且心境稳定剂在治疗抑郁方面似乎不如治疗躁狂有效。初步数据表明，一种已确定的抗癫痫药物拉莫三嗪可能对双相情感障碍相关的抑郁和躁狂均有效。这是第一项评估拉莫三嗪单药治疗双相I型抑郁的对照多中心研究。
195名患有重度抑郁发作的双相I型障碍门诊患者接受拉莫三嗪（50或200毫克/天）或安慰剂单药治疗7周。在每周的每次访视时完成包括汉密尔顿抑郁评定量表（HAM-D）、蒙哥马利-阿斯伯格抑郁评定量表（MADRS）、躁狂评定量表以及临床总体印象严重程度量表（CGI-S）和改善量表（CGI-I）在内的精神科评估。
与安慰剂相比，200毫克/天的拉莫三嗪在17项HAM-D、HAM-D第1项、MADRS、CGI-S和CGI-I上显示出显著的抗抑郁疗效。早在第3周就可见到改善。与安慰剂相比，50毫克/天的拉莫三嗪在多项指标上也显示出疗效。对于200毫克/天拉莫三嗪组、50毫克/天拉莫三嗪组和安慰剂组，在CGI-I上表现出反应的患者比例分别为51%、41%和26%。除拉莫三嗪组头痛发生率较高外，各治疗组的不良事件和其他安全性结果相似。
拉莫三嗪单药治疗是双相抑郁一种有效且耐受性良好的治疗方法。
