Treatment of Suicidal Ideation With Intravenous Ketamine Infusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Suicidality
研究概览
简要总结
This study is dedicated to achieving better treatments for suicidal thoughts. Specifically, the investigators are studying the effect of a medication called ketamine to quickly treat suicidal thoughts and depression.
详细描述
This study is dedicated to achieving better treatments for suicidal thoughts. Specifically, we are studying the effect of a medication called ketamine to quickly treat suicidal thoughts and depression. Patients will be asked to participate in a research study to study how the use of a medication, ketamine, decreases your suicidal thoughts and improves their symptoms of depression. Ketamine is approved by FDA for use at higher doses in anesthesia, and recent clinical research suggests that it might benefit patients with major depressive disorder and suicidal thoughts. During clinical trials with over 10,000 patients, ketamine was proved to be safe as an anesthetic and studies with hundreds of patients with depression have demonstrated safety and lack of lasting side effects. This is a pilot study to test a new use of ketamine: treatment of suicidal thoughts. The study medication will be given in addition to usual psychiatric care.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : 19-64
- •Significant suicidality score on the Columbia Suicide Severity Rating Scale (C-SSRS)
- •Willing and able to provide informed consent.
- •Individuals with current substance abuse are allowed
排除标准
- •Pregnant or lactating; women of reproductive potential must have a negative urine pregnancy test (urine dipstick method)
- •Post-Partum state : defined as being within 2 months of delivery or miscarriage
- •Homicide risk as determined by clinical interview
- •Treatment with any medication known to specifically target the glutamate-NMDA receptor system (ie lamotrigine, acamprosate, memantine, riluzole or lithium)
- •Any known hypersensitivity or serious adverse effect associated with ketamine treatment.
- •Any clinically significant medical condition or therapy that would preclude treatment with ketamine, to include recent myocardial infarction or unstable angina
- •Medically unstable, including acute withdrawal from alcohol or benzodiazepines requiring the use of benzodiazepine treatment.
- •Any of the following DSM-IV diagnoses or categories:
- •Any current psychosis or history of a non-mood psychotic disorder (e.g., schizophrenia)
- •Currently in a manic or mixed episode
- •Current use (defined by urine dipstick test) or abuse of hallucinogenic drugs (except marijuana) such as phencyclidine
- •Any dissociative disorder
- •Any pervasive developmental disorder (e.g., autism)
- •A cognitive disorder (e.g., Alzheimer's Disease)
- •Cluster A personality disorder (e.g., schizoid or schizotypal); note that cluster B and C personality disorders may be included
- •Any eating disorder
研究组 & 干预措施
Suicidal, Depression with Ketamine
suicidal ideation and depression (no substance use disorder) 0.2 mg/kg IV ketamine administered as a one time dose
干预措施: Ketamine (Drug)
Suicidal, Depression with Saline
Suicidal ideation and depression (no substance use disorder) comparable amount of placebo (saline)
干预措施: placebo (Drug)
Suicidal, opioid use with ketamine
suicidal ideation,depression, opioid use disorder 0.2 mg/kg IV ketamine one time dose
干预措施: Ketamine (Drug)
Suicidal, opioid use with Saline
Patients with suicidal ideation and depression with opioid use disorder who are given comparable amount of placebo (saline) as would have been used with the Ketamine arm
干预措施: placebo (Drug)
结局指标
主要结局
Suicidality
时间窗: 2 hours
Scales and questionnaires using the Beck Scale for Suicidal Ideation. The Beck Scale is a self-report questionnaire. The items on this scale identify the presence and severity of suicidal ideation. Beck Scale for Suicidal Ideation has 19 items,preceded by a 5 item screener. Each item is rated on a 3 point scale from 0 to 2. Scores range from 0 to 48. Total scoreScores of 0 - 16 indicate low risk for suicide; scores of 16 or greater indicate higher risk for suicide.
次要结局
- Depression(2 hours)
研究者
Dr. Richard Shelton
Principal Investigator
University of Alabama at Birmingham