Ketamine as an Adjunctive Treatment of Acute Suicidal Ideation in the Emergency Setting.
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Ketamine effect on Suicidal Ideation and Depression.
研究概览
简要总结
The objective of the current program of research will be to test whether intranasal ketamine treatment is more effective than placebo in reducing suicidal ideation in suicidal patients presenting for acute treatment in emergency department settings. Secondary objectives will test the effect of genotypic differences in the mu opioid receptor on efficacy of ketamine and the correlation of speech patterns and facial movement patterns with subjective reductions in suicidal ideation after ketamine treatment.
详细描述
The objective of the current program of research will be to test whether intranasal ketamine treatment is more effective than placebo in reducing suicidal ideation in suicidal patients presenting for acute treatment in emergency department settings. Secondary objectives will test the effect of genotypic differences in the mu opioid receptor on efficacy of ketamine and the correlation of speech patterns and facial movement patterns with subjective reductions in suicidal ideation after ketamine treatment
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females
- •All races and ethnicities
- •Willing and able to provide informed consent
- •A cutoff score of >3 on the Beck Scale for Suicidal Ideation
- •>2 on the Columbia Scale for Suicide Severity Rating
排除标准
- •Pregnancy or lactation; women of reproductive potential must have a negative urine pregnancy test
- •Post-partum state (within 2 months of delivery)
- •Homicide risk as determined by clinical interview
- •Any of the following Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnoses:
- •Any current primary psychotic disorder
- •Acute intoxication or withdrawal from alcohol or any other substance of abuse, as determined by clinical interview and urine drug screen except opioids
- •use of any hallucinogen (except cannabis), in the last month
- •Any dissociative disorder
- •Pervasive developmental disorder
- •Cognitive disorder
- •Cluster A personality disorder
- •Anorexia nervosa.
- •Treatment with any medication known to affect the N-methyl-D-aspartate (NMDA) receptor system (e.g., lamotrigine, acamprosate, memantine, riluzole, or lithium)
- •Any known hypersensitivity or serious adverse effect with ketamine
- •Any clinically-significant medication or condition that would preclude the use of ketamine
研究组 & 干预措施
Intranasal Ketamine
0.2 mg / kg dose of intranasal ketamine for treatment of suicidality will be given in two separate doses on the day of admission to the hospital.
干预措施: Intranasal Ketamine (Drug)
Intranasal Saline Placebo
0.2 mg / kg dose saline intranasal will be given in two separate doses on the day of hospital admission.
干预措施: Intranasal Saline Placebo (Drug)
结局指标
主要结局
Ketamine effect on Suicidal Ideation and Depression.
时间窗: 4 weeks
To assess the acute efficacy and durability of effect over a 4 week time period of single dose of 0.2 mg/kg intranasal ketamine treatment on suicidal ideation and depression in individuals with acute suicidal ideation as measured by the Beck Scale for Suicidal Ideation (BSS) and the Montgomery-Asberg Depression Rating Scale (MADRS)as compared to placebo.
次要结局
- Assessment of Role of Mu Opioid Receptor(4 weeks)
研究者
Cheryl McCullumsmith
Principal Investigator
University of Cincinnati