Effectiveness of adjunctive antidepressant treatment for bipolar depression
Effectiveness of adjunctive antidepressant treatment for bipolar depression
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DOI：
10.1056/nejmoa064135
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发表时间：
2007-04-26
影响因子：
158.5
通讯作者：
Thase, Michael E.
中科院分区：
文献类型：
--
作者：
Sachs, Gary S.;Nierenberg, Andrew A.;Thase, Michael E.
背景：抑郁发作是双相情感障碍患者最常见的致残原因。标准抗抑郁药物治疗双相情感障碍（双相抑郁症）相关抑郁发作的有效性和安全性尚未得到很好的研究。我们的研究旨在确定辅助抗抑郁治疗是否能在不增加躁狂症风险的情况下减轻双相抑郁症的症状。方法：在这项双盲、安慰剂对照研究中，我们随机分配双相抑郁症患者，在常规临床护理的条件下，接受长达26周的情绪稳定剂加辅助抗抑郁治疗或情绪稳定剂加配套安慰剂治疗。在所有随访中使用了一种标准化的临床监测表格，该表格改编自《精神疾病诊断与统计手册》第四版结构化临床访谈中的情绪障碍模块。主要结局是每个治疗组中达到持久恢复标准（连续8周精神状态）的受试者百分比。次要有效性结果和治疗产生的情感转换（在治疗过程早期转向躁狂或轻躁狂）的比率也进行了检查。结果：179名受试者中有42名（23.5%）接受情绪稳定剂加辅助抗抑郁治疗，187名受试者中有51名（27.3%）接受情绪稳定剂加相匹配的安慰剂治疗（P=0.40）。在次要结果中，观察到适度的无显著趋势有利于接受情绪稳定剂加安慰剂的组。在两组中，治疗产生的情感转换率相似。结论：与使用情绪稳定剂相比，使用辅助的标准抗抑郁药物并不会增加疗效，也不会增加治疗后情绪转换的风险。需要长期的结果研究来充分评估抗抑郁药治疗双相情感障碍的益处和风险。
BACKGROUND:Episodes of depression are the most frequent cause of disability among patients with bipolar disorder. The effectiveness and safety of standard antidepressant agents for depressive episodes associated with bipolar disorder (bipolar depression) have not been well studied. Our study was designed to determine whether adjunctive antidepressant therapy reduces symptoms of bipolar depression without increasing the risk of mania.METHODS:In this double-blind, placebo-controlled study, we randomly assigned subjects with bipolar depression to receive up to 26 weeks of treatment with a mood stabilizer plus adjunctive antidepressant therapy or a mood stabilizer plus a matching placebo, under conditions generalizable to routine clinical care. A standardized clinical monitoring form adapted from the mood-disorder modules of the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, was used at all follow-up visits. The primary outcome was the percentage of subjects in each treatment group meeting the criterion for a durable recovery (8 consecutive weeks of euthymia). Secondary effectiveness outcomes and rates of treatment-emergent affective switch (a switch to mania or hypomania early in the course of treatment) were also examined.RESULTS:Forty-two of the 179 subjects (23.5%) receiving a mood stabilizer plus adjunctive antidepressant therapy had a durable recovery, as did 51 of the 187 subjects (27.3%) receiving a mood stabilizer plus a matching placebo (P=0.40). Modest nonsignificant trends favoring the group receiving a mood stabilizer plus placebo were observed across the secondary outcomes. Rates of treatment-emergent affective switch were similar in the two groups.CONCLUSIONS:The use of adjunctive, standard antidepressant medication, as compared with the use of mood stabilizers, was not associated with increased efficacy or with increased risk of treatment-emergent affective switch. Longer-term outcome studies are needed to fully assess the benefits and risks of antidepressant therapy for bipolar disorder.