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

Phase 4

Terminated

Interventions: Drug: Intravenous ketamine
Behavioral: Sham Training
Behavioral: Cognitive training

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Ketamine + Sham Training	Intravenous ketamine	-
Ketamine + Sham Training	Sham Training	-
Ketamine + Cognitive Training	Intravenous ketamine	-
Ketamine + Cognitive Training	Cognitive training	-

Primary Outcome Measures

Name	Time	Method
Adult Suicide Ideation Questionnaire (Past Day Version)	infusion +12 days	suicidal ideation/thoughts; range 0-150; high score=worse outcome
Montgomery Asberg Depression Rating Scale	infusion +6 months	depression severity; range 0-60; high score=worse outcome
Adult Suicide Ideation Questionnaire	infusion +6 months	suicidal ideation/thoughts; range 0-150; high score=worse outcome

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reporting Suicidal Behaviors Per the Columbia Suicide Severity Rating Scale (CSSRS)	infusion +6 months	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.
Scale for Suicide Ideation	infusion +6 months	suicidal ideation/thoughts; range 0-38; high score=worse outcome
Number of Participants With Occurrence of Suicidal Behaviors Per Medical Chart Review	infusion +6 months	Number of participants with occurrence of any suicidal act (derived from medical chart) including: re-attempt, re-hospitalization for suicidality, or completed suicide
Quick Inventory of Depressive Symptoms	infusion +6 months	Self-reported depression (range: 0-27; higher scores = worse outcome)