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Rapid and Sustained Reductions in Current Suicidal Ideation Following Repeated Doses of Intravenous Ketamine: Secondary Analysis of an Open-Label Study

机译:重复剂量静脉注射氯胺酮后,当前自杀观念的快速且持续减少:一项开放标签研究的二级分析

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Background: Ketamine rapidly reduces thoughts of suicide in patients with treatment-resistant depression who are at low risk for suicide. However, the extent to which ketamine reduces thoughts of suicide in depressed patients with current suicidal ideation remains unknown. Methods: Between April 2012 and October 2013, 14 outpatients with DSM-IV–diagnosed major depressive disorder were recruited for the presence of current, stable (≥ 3 months) suicidal thoughts. They received open-label ketamine infusions over 3 weeks (0.5 mg/kg over 45 minutes for the first 3 infusions; 0.75 mg/kg over 45 minutes for the last 3). In this secondary analysis, the primary outcome measures of suicidal ideation (Columbia-Suicide Severity Rating Scale [C-SSRS] and the Suicide Item of the 28-item Hamilton Depression Rating Scale [HDRS28-SI]) were assessed at 240 minutes postinfusion and for 3 months thereafter in a naturalistic follow-up. Results: Over the course of the infusions (acute treatment phase), 7 of 14 patients (50%) showed remission of suicidal ideation on the C-SSRS Ideation scale (even among patients whose depression did not remit). There was a significant linear decrease in this score over time (P .001), which approached significance even after controlling for severity of 6-item Hamilton Depression Rating Scale (HDRS6) core depression items (P = .05). Similarly, there were significant decreases in the C-SSRS Intensity (P .01) and HDRS28-SI (P .001) scores during the acute treatment phase. Two of the 7 patients who achieved remission during the acute treatment phase (29%) maintained their remission throughout a 3-month naturalistic follow-up. Conclusions: In this preliminary study, repeated doses of open-label ketamine rapidly and robustly decreased suicidal ideation in pharmacologically treated outpatients with treatment-resistant depression with stable suicidal thoughts; this decrease was maintained for at least 3 months following the final ketamine infusion in 2 patients. Trial Registration: ClinicalTrials.gov identifier: NCT01582945
机译:背景:氯胺酮迅速降低了自杀风险低的难治性抑郁症患者的自杀念头。然而,氯胺酮在多大程度上降低了目前具有自杀意念的抑郁患者的自杀念头。方法:在2012年4月至2013年10月之间,招募了14名经DSM-IV诊断为重度抑郁症的门诊患者,因为他们存在当前的,稳定的(≥3个月)自杀念头。他们在3周内接受了开放标签的氯胺酮输注(前3次输注在45分钟内为0.5 mg / kg;后3次在45分钟内为0.75 mg / kg)。在该次要分析中,在输注后240分钟评估了自杀意念的主要结局指标(哥伦比亚-自杀严重程度评定量表[C-SSRS]和汉密尔顿抑郁量表[HDRS28-SI]的自杀项目)。之后进行3个月的自然随访。结果:在输液过程中(急性治疗阶段),14例患者中有7例(50%)显示出C-SSRS构想量表的自杀意念得到缓解(即使在抑郁症未缓解的患者中)。随着时间的推移,该评分出现显着的线性下降(P <.001),即使在控制了6个项目的汉密尔顿抑郁量表(HDRS6)核心抑郁项目的严重程度之后,该比率也接近显着性(P = .05)。同样,在急性治疗阶段,C-SSRS强度(P <.01)和HDRS28-SI(P <.001)得分也明显降低。在急性治疗阶段获得缓解的7例患者中,有2例(29%)在为期3个月的自然随访中保持了缓解。结论:在这项初步研究中,反复服用开放标签的氯胺酮可快速,有力地降低具有稳定自杀念头的药物治疗门诊患者的抗药性抑郁症的自杀意念;最终氯胺酮输注2例患者后,这种下降至少维持了3个月。试验注册:ClinicalTrials.gov标识符:NCT01582945

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