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

Phase 4TerminatedNCT04154150

Rebecca Price16 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Suicide, Attempted

Interventions

Intravenous ketamineDRUG

Single subanesthetic infusion of ketamine (0.5mg/kg)

Cognitive trainingBEHAVIORAL

8 sessions of computer-based cognitive training

Sham TrainingBEHAVIORAL

8 sessions of computer-based sham training

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: Participants will: 1. be between the ages of 18 and 65 years 2. be a medical inpatient referred for psychiatric consultation/liaison due to suicidality 3. possess a level of judgment and understanding sufficient to agree to all procedures required by the protocol and must sign an informed consent document 4. 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: 1. Presence of current psychotic or autism spectrum disorder or current delirium 2. Use of a Monoamine Oxidase Inhibitor (MAOI) within the previous 2 weeks 3. Current pregnancy or breastfeeding 4. Reading level \<5th grade as per WRAT-3 reading subtest 5. Past intolerance or hypersensitivity to ketamine 6. Patients taking any of the following medications: St John's Wort, theophylline, tramadol, metrizamide 7. Patients who have received ECT in the past 6 months prior to intake 8. Patients at risk for withdrawal related issues (e.g., delirium tremens, severe opiate withdrawal) or who present with substance-induced psychosis 9. 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

Locations (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Montgomery Asberg Depression Rating Scale

depression severity; range 0-60; high score=worse outcome

Time frame: infusion +24 hours

Montgomery Asberg Depression Rating Scale

depression severity; range 0-60; high score=worse outcome

Time frame: infusion +5 days

Montgomery Asberg Depression Rating Scale

depression severity; range 0-60; high score=worse outcome

Time frame: infusion +12 days

Montgomery Asberg Depression Rating Scale

depression severity; range 0-60; high score=worse outcome

Time frame: infusion +1 month

Montgomery Asberg Depression Rating Scale

depression severity; range 0-60; high score=worse outcome

Time frame: infusion +3 months

Montgomery Asberg Depression Rating Scale

depression severity; range 0-60; high score=worse outcome

Time frame: infusion +6 months

Adult Suicide Ideation Questionnaire (Past Day Version)

suicidal ideation/thoughts; range 0-150; high score=worse outcome

Time frame: infusion +24 hours

Adult Suicide Ideation Questionnaire (Past Day Version)

suicidal ideation/thoughts; range 0-150; high score=worse outcome

Time frame: infusion +5 days

Adult Suicide Ideation Questionnaire (Past Day Version)

Data from ClinicalTrials.gov

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Secondary Outcomes

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

Time frame: 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.

Time frame: infusion +6 months

Quick Inventory of Depressive Symptoms

Self-reported depression (range: 0-27; higher scores = worse outcome)

Time frame: infusion +24 hours

Quick Inventory of Depressive Symptoms

Self-reported depression (range: 0-27; higher scores = worse outcome)

Time frame: infusion +5 days

Quick Inventory of Depressive Symptoms

Self-reported depression (range: 0-27; higher scores = worse outcome)

Time frame: infusion +12 days

Quick Inventory of Depressive Symptoms

Self-reported depression (range: 0-27; higher scores = worse outcome)

Time frame: infusion +1 month

Quick Inventory of Depressive Symptoms

Self-reported depression (range: 0-27; higher scores = worse outcome)

Time frame: infusion +3 months

Quick Inventory of Depressive Symptoms

Self-reported depression (range: 0-27; higher scores = worse outcome)

Time frame: infusion +6 months

Scale for Suicide Ideation