A Randomized, Double-Blind, Placebo-Controlled Trial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol Abuse
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Suicidal Ideation as Assessed by the Scale for Suicide Ideation (SSI)
研究概览
简要总结
This project aims to evaluate the potential rapid and sustained antisuicidal and antidepressant effects of a single intranasal dose of ketamine in inpatients during a mood episode in Major Depressive Disorder (MDD) or Bipolar Disorder (BD) with or without comorbid recent abuse of alcohol.
详细描述
Clinicians have a limited ability to predict imminent suicidal behavior and efficacious treatments are not available to treat suicidal patients. Thus, Rapid-acting treatments for suicidal individuals are truly needed. This project aims to evaluate the potential rapid and sustained antisuicidal and antidepressant effects of a single intranasal dose of ketamine in inpatients during a mood episode (in Major Depressive Disorder, MDD or Bipolar Disorder, BD) with or without comorbid recent abuse of alcohol. These results will elucidate the antisuicidal effects of ketamine using the intranasal route along with the identification of associated mediators or moderators; this approach has the potential for enormous public health impact.
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
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary admission to Harris County Psychiatry Center
- •Able to provide written informed consent
- •Current suicidal ideation and depressive symptoms and Diagnostic and Statistical Manual of Mental Disorders -IV- Text Revision(DSM-IV-TR) depressive episode (also MADRS greater than or equal to 12) and Young Mania Rating Scale (YMRS) score lower than 8
- •DSM-IV-TR criteria for current alcohol abuse (but not intoxicated/withdrawal, abstinent from drinking for > 5 days prior to admission).
- •Lifetime history of suicide attempt (patient)
- •Not taking any medication in the last 24hs.
- •Scale for Suicide Ideation (SSI) score over 4 (first five items) and Columbia scale (C-SSRS) score 4 or 5
排除标准
- •Unstable medical condition or medical problem with known central nervous system (CNS) effects, e.g. uncontrolled hypertension systolic blood pressure (SBP) ≥170 and/or diastolic blood pressure (DBP) ≥100) or recent history (6 months) of alcohol-withdrawal seizures or significant abnormal laboratory tests (liver function test (LFT) 3 times higher than normal).
- •Prior diagnosis of a DSM-IV-TR psychotic spectrum disorder, psychotic symptoms, or personality disorder.
- •Currently under the acute effects of an illicit substance.
- •Pregnant or nursing women.
- •Subjects with a history of DSM-IV drug dependency or abuse (except for caffeine or nicotine dependence) within the preceding 3 months
研究组 & 干预措施
Intranasal ketamine
Intranasal ketamine
干预措施: Intranasal ketamine (Drug)
Placebo
non-active placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Suicidal Ideation as Assessed by the Scale for Suicide Ideation (SSI)
时间窗: 24 hours
The scale contains 19 items rated on a scale from 0 to 2, allowing score range from 0 to 38, score over 4 (first five items) will be considered inclusion criteria. Higher values indicate worsening or presence of suicidal ideation.
次要结局
- Depression as Assessed by the Montgomery-Åsberg Depression Rating Scale (MADRS)(24 hours)
- Snaith-Hamilton Pleasure Scale(24 hours)
- Dissociative State as Assessed by Score on Clinician-Administered Dissociative States Scale (CADSS)(24 hours)
- Alcohol Urge Questionnaire (AUQ)(24 hours)
- Manic Symptoms as Assessed by Score on the Young Mania Rating Scale (YMRS)(24 hours)
研究者
Rodrigo Machado-Vieira, MD, PhD, MSc
Professor of Psychiatry
The University of Texas Health Science Center, Houston