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Pilot Randomized Clinical Trial of an SSRI vs Bupropion: Effects on Suicidal Behavior Ideation and Mood in Major Depression

机译:SSRI与安非他酮的试验性随机临床试验:对抑郁症患者自杀行为观念和情绪的影响

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摘要

Randomized controlled trials in depressed patients selected for elevated suicidal risk are rare. The resultant lack of data leaves uncertainty about treatment in this population. This study compared a serotonin reuptake inhibitor with a noradrenergic/dopaminergic antidepressant in major depression with elevated suicidal risk factors. We conducted a double-blind, randomized, clinical pilot trial of paroxetine (N=36) or bupropion (N=38) in DSM IV major depression with a suicide attempt history or current suicidal ideation. The effects during acute (8 weeks) and continuation treatment (up to 16 weeks) were measured. Main outcomes were suicidal behavior and ideation. The secondary outcome was modified 17-item Hamilton Depression Rating Scale score subtracting the suicide item (mHDRS-17). Treatment was not associated with time to a suicidal event and no treatment main effect or treatment × time interaction on suicidal ideation or mHDRS-17 was found. Exploratory model selection showed modest advantages for paroxetine on: (1) mHDRS-17 (p=0.02); and (2) in a separate model adjusted for baseline depression, for suicidal ideation measured with the Beck Scale for Suicidal Ideation (p=0.03), with benefit increasing with baseline severity. Depressed patients with greater baseline suicidal ideation treated with paroxetine compared with bupropion appeared to experience greater acute improvement in suicidal ideation, after adjusting for global depression. Given the lack of evidence-based pharmacotherapy guidelines for suicidal, depressed patients—an important public health population—this preliminary finding merits further study.
机译:在因自杀风险较高而选择的抑郁症患者中进行的随机对照试验很少。结果缺乏数据,使该人群的治疗不确定。这项研究比较了具有严重自杀危险因素的严重抑郁症中5-羟色胺再摄取抑制剂与去甲肾上腺素能/多巴胺能抗抑郁药的关系。我们在有自杀未遂史或目前有自杀意向的DSM IV重度抑郁症患者中进行了帕罗西汀(N = 36)或安非他酮(N = 38)的双盲,随机临床试验。测量了急性(8周)和持续治疗(长达16周)期间的效果。主要结果是自杀行为和想法。次要结果修改为17项汉密尔顿抑郁量表评分,减去自杀项目(mHDRS-17)。治疗与自杀事件的时间无关,并且未发现治疗的主要效果或治疗×时间对自杀意念或mHDRS-17的相互作用。探索性模型选择显示了帕罗西汀在以下方面的适度优势:(1)mHDRS-17(p = 0.02); (2)在针对基线抑郁进行调整的单独模型中,使用贝克自杀意念量表(p = 0.03)测量的自杀意念,其受益随着基线严重程度的增加而增加。与总安非他酮相比,帕罗西汀治疗的基线自杀观念较大的抑郁症患者在调整了整体抑郁后,自杀观念出现了更大的急性改善。鉴于缺乏针对自杀性抑郁症患者(重要的公共卫生人群)的循证药物治疗指南,这一初步发现值得进一步研究。

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