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

Primary Purpose

Suicide, Attempted

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Intravenous ketamine
Cognitive training
Sham Training
Sponsored by
Rebecca Price
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide, Attempted

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Ketamine + Cognitive Training

Ketamine + Sham Training

Arm Description

Outcomes

Primary Outcome Measures

Montgomery Asberg Depression Rating Scale
depression severity; range 0-60; high score=worse outcome
Montgomery Asberg Depression Rating Scale
depression severity; range 0-60; high score=worse outcome
Montgomery Asberg Depression Rating Scale
depression severity; range 0-60; high score=worse outcome
Montgomery Asberg Depression Rating Scale
depression severity; range 0-60; high score=worse outcome
Montgomery Asberg Depression Rating Scale
depression severity; range 0-60; high score=worse outcome
Montgomery Asberg Depression Rating Scale
depression severity; range 0-60; high score=worse outcome
Adult Suicide Ideation Questionnaire (Past Day Version)
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Adult Suicide Ideation Questionnaire (Past Day Version)
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Adult Suicide Ideation Questionnaire (Past Day Version)
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Adult Suicide Ideation Questionnaire
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Adult Suicide Ideation Questionnaire
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Adult Suicide Ideation Questionnaire
suicidal ideation/thoughts; range 0-150; high score=worse outcome

Secondary Outcome Measures

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
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.
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Scale for Suicide Ideation
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Scale for Suicide Ideation
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Scale for Suicide Ideation
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Scale for Suicide Ideation
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Scale for Suicide Ideation
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Scale for Suicide Ideation
suicidal ideation/thoughts; range 0-38; high score=worse outcome

Full Information

First Posted
November 4, 2019
Last Updated
December 15, 2022
Sponsor
Rebecca Price
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1. Study Identification

Unique Protocol Identification Number
NCT04154150
Brief Title
Ketamine + Cognitive Training for Suicidality in the Medical Setting: Pilot
Official Title
Ketamine + Cognitive Training for Suicidality in the Medical Setting: Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Midway through this pilot study, funding was obtained to support a much larger study of the same interventions in this clinical population. Therefore the pilot study was halted so as not to compete with enrollment for the larger study.
Study Start Date
December 19, 2019 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
March 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rebecca Price

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine + Cognitive Training
Arm Type
Experimental
Arm Title
Ketamine + Sham Training
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
Intravenous ketamine
Intervention Description
Single subanesthetic infusion of ketamine (0.5mg/kg)
Intervention Type
Behavioral
Intervention Name(s)
Cognitive training
Intervention Description
8 sessions of computer-based cognitive training
Intervention Type
Behavioral
Intervention Name(s)
Sham Training
Intervention Description
8 sessions of computer-based sham training
Primary Outcome Measure Information:
Title
Montgomery Asberg Depression Rating Scale
Description
depression severity; range 0-60; high score=worse outcome
Time Frame
infusion +24 hours
Title
Montgomery Asberg Depression Rating Scale
Description
depression severity; range 0-60; high score=worse outcome
Time Frame
infusion +5 days
Title
Montgomery Asberg Depression Rating Scale
Description
depression severity; range 0-60; high score=worse outcome
Time Frame
infusion +12 days
Title
Montgomery Asberg Depression Rating Scale
Description
depression severity; range 0-60; high score=worse outcome
Time Frame
infusion +1 month
Title
Montgomery Asberg Depression Rating Scale
Description
depression severity; range 0-60; high score=worse outcome
Time Frame
infusion +3 months
Title
Montgomery Asberg Depression Rating Scale
Description
depression severity; range 0-60; high score=worse outcome
Time Frame
infusion +6 months
Title
Adult Suicide Ideation Questionnaire (Past Day Version)
Description
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Time Frame
infusion +24 hours
Title
Adult Suicide Ideation Questionnaire (Past Day Version)
Description
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Time Frame
infusion +5 days
Title
Adult Suicide Ideation Questionnaire (Past Day Version)
Description
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Time Frame
infusion +12 days
Title
Adult Suicide Ideation Questionnaire
Description
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Time Frame
infusion +1 month
Title
Adult Suicide Ideation Questionnaire
Description
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Time Frame
infusion +3 months
Title
Adult Suicide Ideation Questionnaire
Description
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Time Frame
infusion +6 months
Secondary Outcome Measure Information:
Title
Number of Participants With Occurrence of Suicidal Behaviors Per Medical Chart Review
Description
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
Title
Number of Participants Reporting Suicidal Behaviors Per the Columbia Suicide Severity Rating Scale (CSSRS)
Description
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
Title
Quick Inventory of Depressive Symptoms
Description
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time Frame
infusion +24 hours
Title
Quick Inventory of Depressive Symptoms
Description
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time Frame
infusion +5 days
Title
Quick Inventory of Depressive Symptoms
Description
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time Frame
infusion +12 days
Title
Quick Inventory of Depressive Symptoms
Description
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time Frame
infusion +1 month
Title
Quick Inventory of Depressive Symptoms
Description
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time Frame
infusion +3 months
Title
Quick Inventory of Depressive Symptoms
Description
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time Frame
infusion +6 months
Title
Scale for Suicide Ideation
Description
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Time Frame
infusion +24 hours
Title
Scale for Suicide Ideation
Description
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Time Frame
infusion +5 days
Title
Scale for Suicide Ideation
Description
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Time Frame
infusion +12 days
Title
Scale for Suicide Ideation
Description
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Time Frame
infusion +1 month
Title
Scale for Suicide Ideation
Description
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Time Frame
infusion +3 months
Title
Scale for Suicide Ideation
Description
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Time Frame
infusion +6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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