Back to resultsKetamine + Cognitive Training for Suicidality in the Medical Setting
Primary Purpose
Suicide, Attempted
Status
Enrolling by invitation
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Intravenous ketamine
Cognitive training
Sham Training
Sponsored by
About this trial
This is an interventional treatment trial for Suicide, Attempted
Eligibility Criteria
Inclusion Criteria:
Participants who receive ketamine will:
- be between the ages of 18 and 65 years
- be a medical inpatient referred for psychiatric consultation/liaison due to suicidality and determined by psychiatric C/L to require inpatient psychiatric hospitalization
- 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/acute psychosis with significant thought disruption, mania, delirium, or dementia, or a diagnosis of developmental disorder with significant language and/or intellectual impairment
- Mini-Mental State Exam (MMSE) < 21
- Current pregnancy or breastfeeding
- Reading level <5th grade as per WRAT-3 reading subtest AND patient declines to have all questionnaire items and task instructions read aloud to them at all assessment points
- Past intolerance or hypersensitivity to ketamine or esketamine
- Patients taking St John's Wort
- Patients who have received ECT in the past 1 month prior to intake
- Patients at ongoing risk for severe substance or alcohol withdrawal related issues (e.g., delirium tremens, severe opiate withdrawal) or who present with substance-induced psychosis
- Arrested or incarcerated individuals brought in by the legal system for medical stabilization
Sites / Locations
- University of Pittsburgh
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Sham Comparator
Active Comparator
Sham Comparator
Arm Label
Ketamine + Cognitive Training
Ketamine + Sham Training
No-infusion (TAU) + Cognitive Training
No-infusion (TAU) + Sham Training
Arm Description
Outcomes
Primary Outcome Measures
Scale for Suicide Ideation
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Montgomery Asberg Depression Rating Scale
depression severity; range 0-60; high score=worse outcome
Suicidal behaviors: medical chart review and Columbia Suicide Severity Rating Scale (CSSRS)
composite measure of # unique occurrences of any suicidal outcome (recorded via either measure) including: re-attempt, re-hospitalization for suicidality, suicide behaviors, or completed suicide
Secondary Outcome Measures
Adult Suicide Ideation Questionnaire
suicidal ideation/thoughts; range 0-150; high score=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
Montgomery Asberg Depression Rating Scale
depression severity; range 0-60; high score=worse outcome
Full Information
NCT ID
NCT04578938
First Posted
October 1, 2020
Last Updated
October 4, 2023
Sponsor
Rebecca Price
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT04578938
Brief Title
Ketamine + Cognitive Training for Suicidality in the Medical Setting
Official Title
Ketamine + Cognitive Training for Suicidality in the Medical Setting
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
March 2, 2026 (Anticipated)
Study Completion Date
March 2, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rebecca Price
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
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: Edits were made to the outcome measures sections to improve clarity regarding the a priori analytic plan with respect to the "Time Frame" of measurements and to reduce redundancies. Timepoints that will be analyzed as trajectories over windows of time and measurements that will be analyzed as composites are now more clearly specified. The previous entries correctly identified all relevant measures and timepoints, but implied incorrectly that each timepoint/measure would be analyzed in isolation.
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
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ketamine + Cognitive Training
Arm Type
Experimental
Arm Title
Ketamine + Sham Training
Arm Type
Sham Comparator
Arm Title
No-infusion (TAU) + Cognitive Training
Arm Type
Active Comparator
Arm Title
No-infusion (TAU) + 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
Scale for Suicide Ideation
Description
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Time Frame
Trajectories from 24hrs through 1 month
Title
Montgomery Asberg Depression Rating Scale
Description
depression severity; range 0-60; high score=worse outcome
Time Frame
Trajectories from 24hrs through 1 month
Title
Suicidal behaviors: medical chart review and Columbia Suicide Severity Rating Scale (CSSRS)
Description
composite measure of # unique occurrences of any suicidal outcome (recorded via either measure) including: re-attempt, re-hospitalization for suicidality, suicide behaviors, or completed suicide
Time Frame
Trajectories from 24hrs through 12 months
Secondary Outcome Measure Information:
Title
Adult Suicide Ideation Questionnaire
Description
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Time Frame
Trajectories from 24hrs through 12 months
Title
Quick Inventory of Depressive Symptoms
Description
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time Frame
Trajectories from 24hrs through 12 months
Title
Scale for Suicide Ideation
Description
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Time Frame
Trajectories from 1 month through 12 months
Title
Montgomery Asberg Depression Rating Scale
Description
depression severity; range 0-60; high score=worse outcome
Time Frame
Trajectories from 1 month through 12 months
Other Pre-specified Outcome Measures:
Title
Implicit Association Test
Description
performance-based "target engagement" measure of suicidal cognition; range = -inf-inf; high score=worse outcome
Time Frame
Trajectories from 24hrs through 1 week
Title
Implicit Association Test
Description
performance-based "target engagement" measure of suicidal cognition; range = -inf-inf; high score=worse outcome
Time Frame
Trajectories from 1 week through 12 months
Title
Acceptability: infusion
Description
self-report slider scale rating; range = 0-100; high score=better rating
Time Frame
Post-CT assessment (approximately +5 days post-randomization)
Title
Satisfaction: infusion
Description
self-report slider scale rating; range = 0-100; high score=better rating
Time Frame
Post-CT assessment (approximately +5 days post-randomization)
Title
Future likelihood of use: infusion
Description
self-report slider scale rating; range = 0-100; high score=better rating
Time Frame
Post-CT assessment (approximately +5 days post-randomization)
Title
Ease of use: Cognitive Training
Description
self-report slider scale rating; range = 0-100; high score=better rating
Time Frame
Post-CT assessment (approximately +5 days post-randomization)
Title
Helpfulness: Cognitive Training
Description
self-report slider scale rating; range = 0-100; high score=better rating
Time Frame
Post-CT assessment (approximately +5 days post-randomization)
Title
Satisfaction: Cognitive Training
Description
self-report slider scale rating; range = 0-100; high score=better rating
Time Frame
Post-CT assessment (approximately +5 days post-randomization)
Title
Future likelihood of use: Cognitive Training
Description
self-report slider scale rating; range = 0-100; high score=better rating
Time Frame
Post-CT assessment (approximately +5 days post-randomization)
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 who receive ketamine will:
be between the ages of 18 and 65 years
be a medical inpatient referred for psychiatric consultation/liaison due to suicidality and determined by psychiatric C/L to require inpatient psychiatric hospitalization
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/acute psychosis with significant thought disruption, mania, delirium, or dementia, or a diagnosis of developmental disorder with significant language and/or intellectual impairment
Mini-Mental State Exam (MMSE) < 21
Current pregnancy or breastfeeding
Reading level <5th grade as per WRAT-3 reading subtest AND patient declines to have all questionnaire items and task instructions read aloud to them at all assessment points
Past intolerance or hypersensitivity to ketamine or esketamine
Patients taking St John's Wort
Patients who have received ECT in the past 1 month prior to intake
Patients at ongoing risk for severe substance or alcohol withdrawal related issues (e.g., delirium tremens, severe opiate withdrawal) or who present with substance-induced psychosis
Arrested or incarcerated individuals brought in by the legal system for medical stabilization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca B Price, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
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
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