重复静脉注射氯胺酮后当前自杀观念迅速且持续减轻：一项开放标签研究的二次分析
Rapid and Sustained Reductions in Current Suicidal Ideation Following Repeated Doses of Intravenous Ketamine: Secondary Analysis of an Open-Label Study.
作者信息
Ionescu Dawn F, Swee Michaela B, Pavone Kara J, Taylor Norman, Akeju Oluwaseun, Baer Lee, Nyer Maren, Cassano Paolo, Mischoulon David, Alpert Jonathan E, Brown Emery N, Nock Matthew K, Fava Maurizio, Cusin Cristina
机构信息
Massachusetts General Hospital, Depression Clinical and Research Program, 1 Bowdoin Sq, 6th Floor, Boston, MA 02114.
Depression Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, Boston.
出版信息
J Clin Psychiatry. 2016 Jun;77(6):e719-25. doi: 10.4088/JCP.15m10056.
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.
背景
氯胺酮能迅速减少自杀风险较低的难治性抑郁症患者的自杀念头。然而，氯胺酮对目前有自杀意念的抑郁症患者自杀念头的减少程度尚不清楚。
方法
在2012年4月至2013年10月期间，招募了14名符合DSM-IV诊断标准的重度抑郁症门诊患者，这些患者目前存在稳定（≥3个月）的自杀念头。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分钟内给予0.5mg/kg；最后3次在45分钟内给予0.75mg/kg）。在这项二次分析中，在输注后240分钟以及此后3个月的自然随访中，评估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28项汉密尔顿抑郁评定量表的自杀项目 [HDRS₂₈-SI]）。
结果
在输注过程中（急性治疗阶段），14名患者中有7名（50%）在C-SSRS意念量表上显示自杀意念缓解（即使在抑郁症未缓解的患者中也是如此）。该分数随时间有显著的线性下降（P <.001），即使在控制了6项汉密尔顿抑郁评定量表（HDRS₆）核心抑郁项目的严重程度后，该下降仍接近显著水平（P = .05）。同样，在急性治疗阶段，C-SSRS强度（P <.01）和HDRS₂₈-SI（P <.001）分数也有显著下降。在急性治疗阶段实现缓解的7名患者中有2名（29%）在3个月的自然随访中维持了缓解状态。
结论
在这项初步研究中，重复剂量的开放标签氯胺酮迅速且显著地减少了经药物治疗的难治性抑郁症且有稳定自杀念头的门诊患者的自杀意念；在2名患者中，最后一次氯胺酮输注后，这种减少至少维持了3个月。
试验注册
ClinicalTrials.gov标识符：NCT01582945。
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