Ketamine + Cognitive Training for Suicidality in the Medical Setting

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Ketamine + Cognitive Training for Suicidality in the Medical Setting

Conditions
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Suicide, Attempted

Intervention / Treatment
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* Drug: Intravenous ketamine
* Behavioral: Cognitive training
* Behavioral: Sham Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who receive ketamine will: be between the ages of 18 and 65 years be a medical inpatient referred for psychiatric consultation/liaison due to suicidality and determined by psychiatric C/L to require inpatient psychiatric hospitalization 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine + Cognitive Training<br> | Drug: Intravenous ketamine<br>* Single subanesthetic infusion of ketamine (0.5mg/kg)<br>Behavioral: Cognitive training<br>* 8 sessions of computer-based cognitive training<br>|
| Sham Comparator: Ketamine + Sham Training<br> | Drug: Intravenous ketamine<br>* Single subanesthetic infusion of ketamine (0.5mg/kg)<br>Behavioral: Sham Training<br>* 8 sessions of computer-based sham training<br>|
| Active Comparator: No-infusion (TAU) + Cognitive Training<br> | Behavioral: Cognitive training<br>* 8 sessions of computer-based cognitive training<br>|
| Sham Comparator: No-infusion (TAU) + Sham Training<br> | Behavioral: Sham Training<br>* 8 sessions of computer-based sham training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scale for Suicide Ideation | suicidal ideation/thoughts; range 0-38; high score=worse outcome | Trajectories from 24hrs through 1 month | 
| Montgomery Asberg Depression Rating Scale | depression severity; range 0-60; high score=worse outcome | Trajectories from 24hrs through 1 month | 
| Suicidal behaviors: medical chart review and Columbia Suicide Severity Rating Scale (CSSRS) | 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 | Trajectories from 24hrs through 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adult Suicide Ideation Questionnaire | suicidal ideation/thoughts; range 0-150; high score=worse outcome | Trajectories from 24hrs through 12 months | 
| Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | Trajectories from 24hrs through 12 months | 
| Scale for Suicide Ideation | suicidal ideation/thoughts; range 0-38; high score=worse outcome | Trajectories from 1 month through 12 months | 
| Montgomery Asberg Depression Rating Scale | depression severity; range 0-60; high score=worse outcome | Trajectories from 1 month through 12 months |