- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04154150
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
Status
Terminated
Conditions
Intervention / Treatment
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
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
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-
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:
- 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
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
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Self-Injurious Behavior
- Suicide
- Suicide, Attempted
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID 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.
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