A randomized, double-blind, placebo-controlled trial of pramipexole augmentation in treatment-resistant major depressive disorder.
A randomized, double-blind, placebo-controlled trial of pramipexole augmentation in treatment-resistant major depressive disorder.
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DOI：
10.4088/jcp.12m08093
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发表时间：
2013-07
期刊：
影响因子：
--
通讯作者：
Perlis RH
中科院分区：
文献类型：
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作者：
Cusin C;Iovieno N;Iosifescu DV;Nierenberg AA;Fava M;Rush AJ;Perlis RH
对严重抑郁障碍(MDD)患者的多种治疗方法已证明有效，但多达三分之一的MDD患者尽管采取了各种干预措施，仍未实现症状缓解。现有的强化或组合策略可能存在大量的安全问题，这可能会限制它们的应用。这项研究在一家三级抑郁症中心进行了一项为期8周的随机、双盲、安慰剂对照试验，调查了灵活剂量的多巴胺激动剂普拉克索作为标准抗抑郁药治疗的辅助药物的抗抑郁效果。我们随机选择了60名门诊患者(年龄在18岁到75岁之间)，根据DSM-IV诊断为难治性非精神病性MDD，分别给予普拉克索(n=30)或安慰剂(n=30)治疗。治疗抵抗被定义为持续抑郁(蒙哥马利-阿斯伯格抑郁评定量表[MADRS]评分≥18)，尽管在当前抑郁发作中至少接受了一种先前的抗抑郁药物治疗。患者是在2005年9月至2008年4月之间招募的。主要的结果衡量标准是MADRS评分。使用混合效应线性回归模型的分析表明，普拉克索有温和但在统计学上显著的益处(P=0.038)。最后一次观察-继续分析表明，随机接受普拉克索强化治疗的患者中，分别有40%和33%的患者有反应(χ2=1.2，P=0.27)和缓解(χ2=0.74，P=.61)，而安慰剂组分别为27%和23%；然而，这些差异没有统计学意义。普拉克索增强治疗耐受性良好，未发现严重不良反应。对于对标准抗抑郁药物治疗无效的患者，普拉克索是一种安全且潜在有效的增强策略。ClinicalTrials.gov标识：NCT00231959
Multiple treatments for patients with major depressive disorder (MDD) have demonstrated efficacy, but up to one-third of individuals with MDD do not achieve symptomatic remission despite various interventions. Existing augmentation or combination strategies can have substantial safety concerns that may limit their application. This study investigated the antidepressant efficacy of a flexible dose of the dopamine agonist pramipexole as an adjunct to standard antidepressant treatment in an 8-week, randomized, double-blind, placebo-controlled trial conducted in a tertiary-level depression center. We randomized 60 outpatients (aged 18 to 75 years) with treatment-resistant nonpsychotic MDD (diagnosed according to DSM-IV) to either pramipexole (n = 30) or placebo (n = 30). Treatment resistance was defined as continued depression (Montgomery-Asberg Depression Rating Scale [MADRS] score ≥ 18) despite treatment with at least 1 prior antidepressant in the current depressive episode. Patients were recruited between September 2005 and April 2008. The primary outcome measure was the MADRS score. The analyses that used a mixed-effects linear regression model indicated a modest but statistically significant benefit for pramipexole (P = .038). The last-observation-carried-forward analyses indicated that 40% and 33% of patients randomized to augmentation with pramipexole achieved response (χ2 = 1.2, P = .27) and remission (χ2 = 0.74, P = .61), respectively, compared to 27% and 23% with placebo; however, those differences were not statistically significant. Augmentation with pramipexole was well-tolerated, with no serious adverse effects identified. For patients who have failed to respond to standard antidepressant therapies, pramipexole is a safe and potentially efficacious augmentation strategy. ClinicalTrials.gov identifier: NCT00231959