普拉克索增效治疗难治性重度抑郁症的随机、双盲、安慰剂对照试验。
A randomized, double-blind, placebo-controlled trial of pramipexole augmentation in treatment-resistant major depressive disorder.
机构信息
Depression Clinical and Research Program, Massachusetts General Hospital, One Bowdoin Square, Ste 630, Boston, MA 02114, USA.
出版信息
J Clin Psychiatry. 2013 Jul;74(7):e636-41. doi: 10.4088/JCP.12m08093.
BACKGROUND
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.
METHOD
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.
RESULTS
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 (χ(2) = 1.2, P = .27) and remission (χ(2) = 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.
CONCLUSION
For patients who have failed to respond to standard antidepressant therapies, pramipexole is a safe and potentially efficacious augmentation strategy.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT00231959.
背景
多项针对重度抑郁症（MDD）患者的治疗方法已证实有效，但仍有多达三分之一的 MDD 患者尽管接受了各种干预措施仍未达到症状缓解。现有的增效或联合治疗策略可能存在严重的安全问题，这可能限制了它们的应用。
方法
本研究在一家三级抑郁症中心进行了为期 8 周的随机、双盲、安慰剂对照试验，以评估多巴胺激动剂普拉克索的灵活剂量作为标准抗抑郁治疗的辅助治疗在治疗抵抗性非精神病性 MDD 患者中的抗抑郁疗效。我们将 60 名（年龄 18 至 75 岁）治疗抵抗性非精神病性 MDD（根据 DSM-IV 诊断）的门诊患者随机分为普拉克索组（n = 30）或安慰剂组（n = 30）。治疗抵抗性定义为尽管在当前抑郁发作中使用了至少一种先前的抗抑郁药，但抑郁仍持续存在（蒙哥马利-阿斯伯格抑郁评定量表[MADRS]评分≥18）。患者于 2005 年 9 月至 2008 年 4 月期间招募。主要结局指标为 MADRS 评分。
结果
使用混合效应线性回归模型的分析表明，普拉克索具有适度但统计学上显著的益处（P =.038）。最后观察到的向前分析表明，与安慰剂组（分别为 χ(2) = 1.2，P =.27）和缓解（χ(2) = 0.74，P =.61）相比，随机分配到普拉克索增效治疗的患者中有 40%和 33%达到了反应和缓解；然而，这些差异没有统计学意义。普拉克索增效治疗耐受性良好，未发现严重不良事件。
结论
对于对抗抑郁药物治疗反应不佳的患者，普拉克索是一种安全且潜在有效的增效策略。
试验注册
ClinicalTrials.gov 标识符：NCT00231959。
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