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

December 15, 2022 updated by: Rebecca Price
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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketamine + Cognitive Training
Single subanesthetic infusion of ketamine (0.5mg/kg)
8 sessions of computer-based cognitive training
Sham Comparator: Ketamine + Sham Training
Single subanesthetic infusion of ketamine (0.5mg/kg)
8 sessions of computer-based sham training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montgomery Asberg Depression Rating Scale
Time Frame: infusion +24 hours
depression severity; range 0-60; high score=worse outcome
infusion +24 hours
Montgomery Asberg Depression Rating Scale
Time Frame: infusion +5 days
depression severity; range 0-60; high score=worse outcome
infusion +5 days
Montgomery Asberg Depression Rating Scale
Time Frame: infusion +12 days
depression severity; range 0-60; high score=worse outcome
infusion +12 days
Montgomery Asberg Depression Rating Scale
Time Frame: infusion +1 month
depression severity; range 0-60; high score=worse outcome
infusion +1 month
Montgomery Asberg Depression Rating Scale
Time Frame: infusion +3 months
depression severity; range 0-60; high score=worse outcome
infusion +3 months
Montgomery Asberg Depression Rating Scale
Time Frame: infusion +6 months
depression severity; range 0-60; high score=worse outcome
infusion +6 months
Adult Suicide Ideation Questionnaire (Past Day Version)
Time Frame: infusion +24 hours
suicidal ideation/thoughts; range 0-150; high score=worse outcome
infusion +24 hours
Adult Suicide Ideation Questionnaire (Past Day Version)
Time Frame: infusion +5 days
suicidal ideation/thoughts; range 0-150; high score=worse outcome
infusion +5 days
Adult Suicide Ideation Questionnaire (Past Day Version)
Time Frame: infusion +12 days
suicidal ideation/thoughts; range 0-150; high score=worse outcome
infusion +12 days
Adult Suicide Ideation Questionnaire
Time Frame: infusion +1 month
suicidal ideation/thoughts; range 0-150; high score=worse outcome
infusion +1 month
Adult Suicide Ideation Questionnaire
Time Frame: infusion +3 months
suicidal ideation/thoughts; range 0-150; high score=worse outcome
infusion +3 months
Adult Suicide Ideation Questionnaire
Time Frame: infusion +6 months
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
Time Frame: 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
infusion +6 months
Number of Participants Reporting Suicidal Behaviors Per the Columbia Suicide Severity Rating Scale (CSSRS)
Time Frame: 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.
infusion +6 months
Quick Inventory of Depressive Symptoms
Time Frame: infusion +24 hours
Self-reported depression (range: 0-27; higher scores = worse outcome)
infusion +24 hours
Quick Inventory of Depressive Symptoms
Time Frame: infusion +5 days
Self-reported depression (range: 0-27; higher scores = worse outcome)
infusion +5 days
Quick Inventory of Depressive Symptoms
Time Frame: infusion +12 days
Self-reported depression (range: 0-27; higher scores = worse outcome)
infusion +12 days
Quick Inventory of Depressive Symptoms
Time Frame: infusion +1 month
Self-reported depression (range: 0-27; higher scores = worse outcome)
infusion +1 month
Quick Inventory of Depressive Symptoms
Time Frame: infusion +3 months
Self-reported depression (range: 0-27; higher scores = worse outcome)
infusion +3 months
Quick Inventory of Depressive Symptoms
Time Frame: infusion +6 months
Self-reported depression (range: 0-27; higher scores = worse outcome)
infusion +6 months
Scale for Suicide Ideation
Time Frame: infusion +24 hours
suicidal ideation/thoughts; range 0-38; high score=worse outcome
infusion +24 hours
Scale for Suicide Ideation
Time Frame: infusion +5 days
suicidal ideation/thoughts; range 0-38; high score=worse outcome
infusion +5 days
Scale for Suicide Ideation
Time Frame: infusion +12 days
suicidal ideation/thoughts; range 0-38; high score=worse outcome
infusion +12 days
Scale for Suicide Ideation
Time Frame: infusion +1 month
suicidal ideation/thoughts; range 0-38; high score=worse outcome
infusion +1 month
Scale for Suicide Ideation
Time Frame: infusion +3 months
suicidal ideation/thoughts; range 0-38; high score=worse outcome
infusion +3 months
Scale for Suicide Ideation
Time Frame: infusion +6 months
suicidal ideation/thoughts; range 0-38; high score=worse outcome
infusion +6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2019

Primary Completion (Actual)

March 15, 2022

Study Completion (Actual)

March 15, 2022

Study Registration Dates

First Submitted

November 4, 2019

First Submitted That Met QC Criteria

November 4, 2019

First Posted (Actual)

November 6, 2019

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

December 15, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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