Ketamine + Cognitive Training for Suicidality in the Medical Setting: Pilot
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Adult Suicide Ideation Questionnaire (Past Day Version)
研究概览
简要总结
This project seeks to identify the acute and longer-term impact of a single dose of intravenous ketamine among suicidal patients referred for psychiatric consultation/liaison in the medical inpatient setting. The investigators will then test whether ketamine's rapid effects can be extended by introducing helpful information delivered by a computer-based training protocol. This work could ultimately lead to the ability to treat suicidality more efficiently and with broader dissemination by rapidly priming the brain for helpful forms of learning.
详细描述
NOTE: In the course of this pilot study, both the primary and secondary outcome measures were supplemented to provide additional, complementary information on the clinical effects of the study interventions, based on confirmation (through study team experience) of the feasibility of acquiring such additional information in the context of our study population, setting, and design.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Participants will:
- •be between the ages of 18 and 65 years
- •be a medical inpatient referred for psychiatric consultation/liaison due to suicidality
- •possess a level of judgment and understanding sufficient to agree to all procedures required by the protocol and must sign an informed consent document
- •be deemed an appropriate and reasonable medical candidate for intravenous ketamine by a physician authorized to prescribe medication to the patient during inpatient hospitalization
排除标准
- •Presence of current psychotic or autism spectrum disorder or current delirium
- •Use of a Monoamine Oxidase Inhibitor (MAOI) within the previous 2 weeks
- •Current pregnancy or breastfeeding
- •Reading level <5th grade as per WRAT-3 reading subtest
- •Past intolerance or hypersensitivity to ketamine
- •Patients taking any of the following medications: St John's Wort, theophylline, tramadol, metrizamide
- •Patients who have received ECT in the past 6 months prior to intake
- •Patients at risk for withdrawal related issues (e.g., delirium tremens, severe opiate withdrawal) or who present with substance-induced psychosis
- •Patients who, based on expressed preference and/or home geographic location, are deemed by the Psychiatric Consultation/Liaison service to be likely to receive inpatient psychiatric hospitalization at an alternate location outside of Western Psychiatric Institute & Clinic
研究组 & 干预措施
Ketamine + Sham Training
干预措施: Sham Training (Behavioral)
Ketamine + Sham Training
干预措施: Intravenous ketamine (Drug)
Ketamine + Cognitive Training
干预措施: Intravenous ketamine (Drug)
Ketamine + Cognitive Training
干预措施: Cognitive training (Behavioral)
结局指标
主要结局
Adult Suicide Ideation Questionnaire (Past Day Version)
时间窗: infusion +12 days
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Montgomery Asberg Depression Rating Scale
时间窗: infusion +6 months
depression severity; range 0-60; high score=worse outcome
Adult Suicide Ideation Questionnaire
时间窗: infusion +6 months
suicidal ideation/thoughts; range 0-150; high score=worse outcome
次要结局
- Number of Participants Reporting Suicidal Behaviors Per the Columbia Suicide Severity Rating Scale (CSSRS)(infusion +6 months)
- Scale for Suicide Ideation(infusion +6 months)
- Number of Participants With Occurrence of Suicidal Behaviors Per Medical Chart Review(infusion +6 months)
- Quick Inventory of Depressive Symptoms(infusion +6 months)
研究者
Rebecca Price
Associate Professor of Psychiatry and Psychology
University of Pittsburgh