Ketamine + Cognitive Training for Suicidality in the Medical Setting: Pilot

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: 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.

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

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 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 Exclusion Criteria: 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

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>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery Asberg Depression Rating Scale | depression severity; range 0-60; high score=worse outcome | infusion +24 hours | 
| Montgomery Asberg Depression Rating Scale | depression severity; range 0-60; high score=worse outcome | infusion +5 days | 
| Montgomery Asberg Depression Rating Scale | depression severity; range 0-60; high score=worse outcome | infusion +12 days | 
| Montgomery Asberg Depression Rating Scale | depression severity; range 0-60; high score=worse outcome | infusion +1 month | 
| Montgomery Asberg Depression Rating Scale | depression severity; range 0-60; high score=worse outcome | infusion +3 months | 
| Montgomery Asberg Depression Rating Scale | depression severity; range 0-60; high score=worse outcome | infusion +6 months | 
| Adult Suicide Ideation Questionnaire (Past Day Version) | suicidal ideation/thoughts; range 0-150; high score=worse outcome | infusion +24 hours | 
| Adult Suicide Ideation Questionnaire (Past Day Version) | suicidal ideation/thoughts; range 0-150; high score=worse outcome | infusion +5 days | 
| Adult Suicide Ideation Questionnaire (Past Day Version) | suicidal ideation/thoughts; range 0-150; high score=worse outcome | infusion +12 days | 
| Adult Suicide Ideation Questionnaire | suicidal ideation/thoughts; range 0-150; high score=worse outcome | infusion +1 month | 
| Adult Suicide Ideation Questionnaire | suicidal ideation/thoughts; range 0-150; high score=worse outcome | infusion +3 months | 
| Adult Suicide Ideation Questionnaire | suicidal ideation/thoughts; range 0-150; high score=worse outcome | infusion +6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Occurrence of Suicidal Behaviors Per Medical Chart Review | Number of participants with occurrence of any suicidal act (derived from medical chart) including: re-attempt, re-hospitalization for suicidality, or completed suicide | infusion +6 months | 
| Number of Participants Reporting Suicidal Behaviors Per the Columbia Suicide Severity Rating Scale (CSSRS) | Number of participants with occurrence of any suicidal act (derived from Columbia Suicide Severity Rating Scale interview; each of the following items was scored yes/no for the period since last assessment: re-attempt, re-hospitalization for suicidality, or completed suicide. Analyzed outcome measure is # of participants with 1 or more 'yes' responses. | infusion +6 months | 
| Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | infusion +24 hours | 
| Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | infusion +5 days | 
| Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | infusion +12 days | 
| Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | infusion +1 month | 
| Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | infusion +3 months | 
| Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) | infusion +6 months | 
| Scale for Suicide Ideation | suicidal ideation/thoughts; range 0-38; high score=worse outcome | infusion +24 hours | 
| Scale for Suicide Ideation | suicidal ideation/thoughts; range 0-38; high score=worse outcome | infusion +5 days | 
| Scale for Suicide Ideation | suicidal ideation/thoughts; range 0-38; high score=worse outcome | infusion +12 days | 
| Scale for Suicide Ideation | suicidal ideation/thoughts; range 0-38; high score=worse outcome | infusion +1 month | 
| Scale for Suicide Ideation | suicidal ideation/thoughts; range 0-38; high score=worse outcome | infusion +3 months | 
| Scale for Suicide Ideation | suicidal ideation/thoughts; range 0-38; high score=worse outcome | infusion +6 months |