Vande Voort Jennifer L, Morgan Robert J, Kung Simon, Rasmussen Keith G, Rico Jose, Palmer Brian A, Schak Kathryn M, Tye Susannah J, Ritter Matthew J, Frye Mark A, Bobo William V
Department of Psychiatry & Psychology, Mayo Clinic Depression Center, Mayo Clinic, Rochester, MN, USA.
Department of Anesthesia, Mayo Clinic, Rochester, MN, USA.
J Affect Disord. 2016 Dec;206:300-304. doi: 10.1016/j.jad.2016.09.008. Epub 2016 Sep 12.
Little is known about the antidepressive effects of repeated intravenous ketamine infusions beyond the acute phase of treatment in patients with refractory depression.
Twelve subjects with treatment-resistant non-psychotic unipolar or bipolar major depression and suicidal ideation were given repeated (up to 6) thrice-weekly acute-phase intravenous infusions of ketamine (0.5mg/kg, administered over 100min). Those who remitted during acute-phase treatment received continuation-phase treatment that consisted of 4 weekly ketamine infusions, followed by 4 weeks of post-continuation phase follow-up (during which no further ketamine infusions were administered). Clinical measures were assessed at baseline, at 24h following each infusion, at the last acute-phase observation, and during continuation and post-continuation follow-up (acute phase remitters only).
Of the 12 enrollees, 5 (41.7%) remitted and 7 (58.3%) responded to ketamine treatment during the acute-phase. All five subjects who remitted during the acute-phase experienced further depressive symptom improvement during continuation-phase treatment. Four subjects lost remission status during the post-continuation phase, but all were still classified as positive treatment responders at the end of the post-continuation phase. Adverse effects were generally mild and transient during acute- and continuation-phase treatment; however, one subject developed behavioral outbursts and suicide threats during follow-up while hospitalized, and one subject died by suicide several weeks after the end of follow-up.
This was an uncontrolled feasibility study with a small sample size.
The continuation-phase administration of ketamine at weekly intervals to patients with treatment-resistant depression who remitted during acute-phase ketamine treatment can extend the duration of depressive symptom remission. The antidepressive effect of ketamine persisted for several weeks after the end of continuation-phase treatment. Our results highlight the need for close monitoring of subjects who are at high baseline risk for suicide but do not respond clinically to ketamine. CLINICALTRIALS.
NCT02094898.
对于难治性抑郁症患者，在治疗急性期之后重复静脉注射氯胺酮的抗抑郁作用了解甚少。
12名患有难治性非精神病性单相或双相重度抑郁症且有自杀观念的受试者接受了重复（最多6次）的每周三次急性期静脉注射氯胺酮（0.5mg/kg，在100分钟内给药）。在急性期治疗期间缓解的患者接受维持期治疗，包括每周4次氯胺酮注射，随后是4周的维持期后随访（在此期间不再进行氯胺酮注射）。在基线、每次注射后24小时、最后一次急性期观察时以及维持期和维持期后随访期间（仅针对急性期缓解者）评估临床指标。
12名受试者中，5名（41.7%）在急性期缓解，7名（58.3%）对氯胺酮治疗有反应。在急性期缓解的所有5名受试者在维持期治疗期间抑郁症状进一步改善。4名受试者在维持期后失去缓解状态，但在维持期后结束时均仍被归类为积极治疗反应者。在急性期和维持期治疗期间，不良反应一般较轻且短暂；然而，一名受试者在住院随访期间出现行为爆发和自杀威胁，一名受试者在随访结束几周后自杀身亡。
这是一项样本量小的非对照可行性研究。
对于在急性期氯胺酮治疗期间缓解的难治性抑郁症患者，每周一次持续给予氯胺酮可延长抑郁症状缓解的持续时间。氯胺酮的抗抑郁作用在维持期治疗结束后持续数周。我们的结果强调需要密切监测基线自杀风险高但对氯胺酮无临床反应的受试者。临床试验。
NCT02094898
