Ketamine: Its Effects on Suicidal Ideations and Inpatient Hospital Length of Stay
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Inpatient Hospital Length of Stay
研究概览
简要总结
This study will evaluate the effect of ketamine on the treatment of patients hospitalized with suicidal thoughts. Half of the patients will receive one dose of ketamine in the vein. The other half will receive a placebo. Because we think that ketamine will improve depression and suicidal thoughts, we expect that patients who receive ketamine will require less time in the hospital than patients who receive placebo.
详细描述
Patients admitted to UMMC's psychiatry inpatient unit with suicidal thoughts will be given the opportunity to participate in the study. Those patients who consent to participate, after being informed about the study and its risks, will be randomized to receive an IV infusion of either saline or ketamine 0.5 mg/kg. The infusion will be given within 24 hours of arriving on the psychiatry inpatient unit. We will record the dates and times that the patient was admitted to and discharged from the psychiatric inpatient unit. At completion of the study, we will compare the average length of stay, defined as date and time of discharge minus date of time of admission, of the group that received ketamine to the average length of stay of the group that received placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between the ages of 18 and 64
- •Patients admitted to the University of Mississippi Medical Center inpatient psychiatry service with suicidal ideations
排除标准
- •Lifetime history of schizophrenia or other primary psychotic disorder
- •Current psychotic or manic symptoms
- •Substance use disorder within one month of admission
- •Positive urine toxicology at admission
- •Any lifetime abuse of ketamine or phencyclidine
- •Systolic BP >180 mmHg or diastolic BP >110 mmHg
- •Any patient who has eaten food within 8 hours prior to receiving the ketamine infusion or who has drank clear liquids within 2 hours prior to receiving the infusion
- •Known central nervous system (CNS) mass
- •CNS abnormalities
- •Hydrocephalus
- •Acute globe injury
- •Untreated thyroid disease
- •Known coronary artery disease with poor functional capacity
- •Currently breast-feeding
研究组 & 干预措施
Ketamine infusion
Assignment to this arm involves receiving a single IV infusion of ketamine 0.5 mg/kg given over 45 minutes.
干预措施: Ketamine (Drug)
Normal Saline infusion
Assignment to this arm involves receiving an IV infusion of normal saline over the course of 45 minutes.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Inpatient Hospital Length of Stay
时间窗: The dates and times of each patients' admission to and discharge from the inpatient unit (i.e., the data necessary to calculate length of stay) were collected by chart review performed approximately 6 months after enrollment in the study.
We defined length of hospital stay as the difference between 1) the date and time that the patient was admitted to the psychiatry inpatient unit and 2) the date and time that the patient was discharged from the psychiatry inpatient.
次要结局
未报告次要终点
研究者
Allen Richert
Associate Professor of Psychiatry and Human Behavior
University of Mississippi Medical Center