Intramuscular Ketamine Administration for the Treatment of Acute Suicidal Ideation With Concurrent EEG Monitoring
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in Auditory Mismatch Negativity (EEG)
研究概览
简要总结
The objective of the present research protocol, a cross-over, subject-blinded, clinical trial, is to correlate changes in brain activity with reduction in suicidal ideation in response to a single intramuscular dose of ketamine. While ketamine is increasingly used as a rapid, antidepressant agent, there is accumulating evidence of additional anti-suicidal properties that may be distinct from its effects on depression. This pilot study will be used to determine (1) whether specific electroencephalogram (EEG) findings are correlated with response of SI to intramuscular (IM) ketamine, and (2) the effectiveness of IM ketamine in the treatment of acute SI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current clinically significant suicidal ideation, defined as a score of > or = 4 on the MADRS item 10 and a positive answer on items 3,4 or 5 of the C-SSRS.
- •Inpatient status at the time of study initiation.
- •18 to 70 years of age
- •Capacity to consent
- •Exclusion criteria:
- •Diagnosis of a primary psychotic disorder (e.g., schizoaffective disorder)
- •Diagnosis of pervasive developmental disorder
- •Diagnosis of a major neurocognitive disorder
- •A positive urine pregnancy test
- •Currently breastfeeding
- •Drug or alcohol abuse or dependence within the preceding 3 months; a rather narrow time period was chosen, however, in order to allow participation by individuals with a history of substance abuse or dependence problems that could be secondary to their SI, and to more closely approximate patients seen in real-world settings. Given the increasingly widespread use of marijuana, and in an effort to recruit a naturalistic study population, concurrent marijuana use is not an exclusion criterion, as long as they are not actively intoxicated.
- •Current positive UTOX for amphetamine, benzodiazepines, cocaine, opiates (if not prescribed)
- •Medical issues or laboratory abnormalities requiring acute intervention
- •Patients for whom an increase in blood pressure or intracranial pressure would pose a serious risk (e.g., aneurysmal vascular disease, arteriovenous malformation, history of intracerebral hemorrhage, unstable angina)
- •Any lifetime history of ketamine or phencyclidine abuse
- •A known hypersensitivity to or history of a serious adverse effect from to ketamine
排除标准
- 未提供
研究组 & 干预措施
Ketamine (1) then Placebo (2)
Participants will receive an intramuscular injection of racemic ketamine, followed the next day by an intramuscular injection of saline (placebo)
干预措施: Ketamine (Ketalar) (Drug)
Ketamine (1) then Placebo (2)
Participants will receive an intramuscular injection of racemic ketamine, followed the next day by an intramuscular injection of saline (placebo)
干预措施: Placebo (Drug)
Placebo (1) then Ketamine (2)
Participants will receive an intramuscular injection of saline (placebo), followed the next day by an intramuscular injection of racemic ketamine
干预措施: Ketamine (Ketalar) (Drug)
Placebo (1) then Ketamine (2)
Participants will receive an intramuscular injection of saline (placebo), followed the next day by an intramuscular injection of racemic ketamine
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Auditory Mismatch Negativity (EEG)
时间窗: Baseline and One hour post injection
Change in Mismatch Negativity (MMN) amplitude or latency from baseline up to one hour after injection.
次要结局
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) #10 (SI)(Baseline and 24 hours post injection)
研究者
Matthew Klein
Assistant Professor
Icahn School of Medicine at Mount Sinai