Ketamine + Cognitive Training for Suicidality in the Medical Setting
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Montgomery Asberg Depression Rating Scale
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: Edits were made to the outcome measures sections to improve clarity regarding the a priori analytic plan with respect to the "Time Frame" of measurements and to reduce redundancies. Timepoints that will be analyzed as trajectories over windows of time and measurements that will be analyzed as composites are now more clearly specified. The previous entries correctly identified all relevant measures and timepoints, but implied incorrectly that each timepoint/measure would be analyzed in isolation.
03/19/26: Edit to upper age limit made to correct a previous data entry error and align with IRB-approved protocol.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who receive ketamine will:
- •be between the ages of 18 and 70 years
- •be a medical inpatient referred for psychiatric consultation/liaison due to suicidality and determined by psychiatric C/L to require follow-up psychiatric care (inpatient or outpatient)
- •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/acute psychosis with significant thought disruption, mania, delirium, or dementia, or a diagnosis of developmental disorder with significant language and/or intellectual impairment
- •Mini-Mental State Exam (MMSE) < 21
- •Current pregnancy or breastfeeding
- •Reading level <5th grade as per WRAT-3 reading subtest AND patient declines to have all questionnaire items and task instructions read aloud to them at all assessment points
- •Past intolerance or hypersensitivity to ketamine or esketamine
- •Patients taking St John's Wort
- •Patients who have received ECT in the past 1 month prior to intake
- •Patients at ongoing risk for severe substance or alcohol withdrawal related issues (e.g., delirium tremens, severe opiate withdrawal) or who present with substance-induced psychosis
- •Arrested or incarcerated individuals brought in by the legal system for medical stabilization
研究组 & 干预措施
Ketamine + Cognitive Training
干预措施: Intravenous ketamine (Drug)
Ketamine + Cognitive Training
干预措施: Cognitive training (Behavioral)
Ketamine + Sham Training
干预措施: Intravenous ketamine (Drug)
Ketamine + Sham Training
干预措施: Sham Training (Behavioral)
No-infusion (TAU) + Cognitive Training
干预措施: Cognitive training (Behavioral)
No-infusion (TAU) + Sham Training
干预措施: Sham Training (Behavioral)
结局指标
主要结局
Montgomery Asberg Depression Rating Scale
时间窗: Trajectories from 24hrs through 1 month
depression severity; range 0-60; high score=worse outcome
Suicidal behaviors: medical chart review and Columbia Suicide Severity Rating Scale (CSSRS)
时间窗: Trajectories from 24hrs through 12 months
composite measure of # unique occurrences of any suicidal outcome (recorded via either measure) including: re-attempt, re-hospitalization for suicidality, suicide behaviors, or completed suicide
Scale for Suicide Ideation
时间窗: Trajectories from 24hrs through 1 month
suicidal ideation/thoughts; range 0-38; high score=worse outcome
次要结局
- Adult Suicide Ideation Questionnaire(Trajectories from 24hrs through 12 months)
- Quick Inventory of Depressive Symptoms(Trajectories from 24hrs through 12 months)
- Scale for Suicide Ideation(Trajectories from 1 month through 12 months)
- Montgomery Asberg Depression Rating Scale(Trajectories from 1 month through 12 months)
研究者
Rebecca Price
Associate Professor of Psychiatry and Psychology
University of Pittsburgh