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

July 18, 2024 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

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ketamine + Cognitive Training
Drug: Intravenous ketamine
Single subanesthetic infusion of ketamine (0.5mg/kg)
Behavioral: Cognitive training
8 sessions of computer-based cognitive training
Sham Comparator: Ketamine + Sham Training
Drug: Intravenous ketamine
Single subanesthetic infusion of ketamine (0.5mg/kg)
Behavioral: Sham Training
8 sessions of computer-based sham training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rebecca Price

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 19, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY19100041 (Part 1)

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings