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首页> 外文期刊>The journal of clinical psychiatry >Efficacy of risperidone augmentation to antidepressants in the management of suicidality in major depressive disorder: a randomized, double-blind, placebo-controlled pilot study.
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Efficacy of risperidone augmentation to antidepressants in the management of suicidality in major depressive disorder: a randomized, double-blind, placebo-controlled pilot study.

机译：利培酮增强抗抑郁药在重大抑郁症患者自杀性管理中的作用：一项随机，双盲，安慰剂对照的试验研究。

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OBJECTIVE: Major depressive disorder (MDD) is a severe mental illness with high risk of suicidality. Antidepressant treatment alone is not sufficient for the acute management of risk-taking symptoms of depression. This pilot study was designed to investigate the efficacy of risperidone augmentation to antidepressants in the acute management of suicidality and other core symptoms in MDD with suicidality. METHOD: Twenty-four adult men and women diagnosed with MDD (DSM-IV), having a depressive episode with suicidality despite taking an antidepressant, were enrolled in an 8-week double-blind, placebo-controlled study. Subjects were randomly assigned to receive risperidone (0.25-2 mg/day) or placebo while continuing on their antidepressant therapy. Clinical efficacy in suicidality, depressive symptoms, and impulsivity were assessed after treatment with study drugs for 4 days, weekly for 4 weeks, then every other week for 4 weeks. Adverse events were also recorded at each visit. The study was conducted from June 2004 to April 2007. RESULTS: Risperidone significantly reduced suicidal ideations in MDD patients, and the overall effect of risperidone appeared to be superior to placebo. The effect of risperidone was rapid, with onset at 2 weeks' treatment, and was sustained along the course of 8 weeks' treatment. Furthermore, risperidone demonstrated superiority to placebo in improving other symptoms related to suicidality and having better trial completion rate, and the low dose risperidone was well tolerated by subjects in this study. CONCLUSION: Data from this pilot study suggest that risperidone is beneficial as an augmenting treatment in MDD patients who have developed high-risk suicidal ideation during a depressive episode. The antisuicidality effect of risperidone is especially valuable in the acute management of severe depressive symptoms. Although the pilot study is limited by small sample size, the promising results warrant further larger scale investigation in the efficacy of atypical antipsychotics in thetreatment of severe depression with suicidality. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00167154.
机译：目的：重度抑郁症（MDD）是一种严重的精神疾病，具有自杀的高风险。仅抗抑郁药治疗不足以对抑郁症的冒险症状进行急性治疗。这项初步研究旨在研究利培酮增强抗抑郁药在自杀和MDD合并自杀的其他核心症状的急性治疗中的功效。方法：二十四名诊断为MDD（DSM-IV）的成年男性和女性，尽管服用了抗抑郁药，但仍有自杀性的抑郁发作，参加了为期8周的双盲，安慰剂对照研究。在继续进行抗抑郁治疗的同时，受试者被随机分配接受利培酮（0.25-2 mg /天）或安慰剂。在用研究药物治疗4天后，每周4周，然后每隔4周一次，评估其对自杀，抑郁症状和冲动的临床疗效。每次访视也记录不良事件。该研究于2004年6月至2007年4月进行。结果：利培酮显着降低了MDD患者的自杀意识，利培酮的总体疗效似乎优于安慰剂。利培酮的作用迅速，在治疗2周时开始发作，并且在治疗8周的过程中一直持续。此外，利培酮在改善与自杀有关的其他症状方面具有优于安慰剂的作用，并且具有较好的试验完成率，并且该研究对象对低剂量利培酮具有良好的耐受性。结论：这项前瞻性研究的数据表明，利培酮对抑郁症发作中具有高自杀意念的MDD患者有益，可作为增强治疗。利培酮的抗自杀作用在严重抑郁症状的急性治疗中特别有价值。尽管该试点研究受到样本量的限制，但有希望的结果值得在非典型抗精神病药治疗具有自杀倾向的严重抑郁症的疗效方面进行进一步的大规模研究。试验注册：clinicaltrials.gov标识符：NCT00167154。

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