Ketamine + Cognitive Training for Suicidality in the Medical Setting

March 19, 2026 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.
Active, not recruiting

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: 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.

03/19/26: Edit to upper age limit made to correct a previous data entry error and align with IRB-approved protocol.

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.
200

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 who receive ketamine will:

  1. be between the ages of 18 and 70 years
  2. be a medical inpatient referred for psychiatric consultation/liaison due to suicidality and determined by psychiatric C/L to require follow-up psychiatric care (inpatient or outpatient)
  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/acute psychosis with significant thought disruption, mania, delirium, or dementia, or a diagnosis of developmental disorder with significant language and/or intellectual impairment
  2. Mini-Mental State Exam (MMSE) < 21
  3. Current pregnancy or breastfeeding
  4. 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
  5. Past intolerance or hypersensitivity to ketamine or esketamine
  6. Patients taking St John's Wort
  7. Patients who have received ECT in the past 1 month prior to intake
  8. 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
  9. Arrested or incarcerated individuals brought in by the legal system for medical stabilization

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
Active Comparator: No-infusion (TAU) + Cognitive Training
Behavioral: Cognitive training
8 sessions of computer-based cognitive training
Sham Comparator: No-infusion (TAU) + Sham Training
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
Scale for Suicide Ideation
Time Frame: Trajectories from 24hrs through 1 month
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Trajectories from 24hrs through 1 month
Montgomery Asberg Depression Rating Scale
Time Frame: Trajectories from 24hrs through 1 month
depression severity; range 0-60; high score=worse outcome
Trajectories from 24hrs through 1 month
Suicidal behaviors: medical chart review and Columbia Suicide Severity Rating Scale (CSSRS)
Time Frame: Trajectories from 24hrs through 12 months
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
Trajectories from 24hrs through 12 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
Adult Suicide Ideation Questionnaire
Time Frame: Trajectories from 24hrs through 12 months
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Trajectories from 24hrs through 12 months
Quick Inventory of Depressive Symptoms
Time Frame: Trajectories from 24hrs through 12 months
Self-reported depression (range: 0-27; higher scores = worse outcome)
Trajectories from 24hrs through 12 months
Scale for Suicide Ideation
Time Frame: Trajectories from 1 month through 12 months
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Trajectories from 1 month through 12 months
Montgomery Asberg Depression Rating Scale
Time Frame: Trajectories from 1 month through 12 months
depression severity; range 0-60; high score=worse outcome
Trajectories from 1 month through 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Implicit Association Test
Time Frame: Trajectories from 24hrs through 1 week
performance-based "target engagement" measure of suicidal cognition; range = -inf-inf; high score=worse outcome
Trajectories from 24hrs through 1 week
Implicit Association Test
Time Frame: Trajectories from 1 week through 12 months
performance-based "target engagement" measure of suicidal cognition; range = -inf-inf; high score=worse outcome
Trajectories from 1 week through 12 months
Acceptability: infusion
Time Frame: Post-CT assessment (approximately +5 days post-randomization)
self-report slider scale rating; range = 0-100; high score=better rating
Post-CT assessment (approximately +5 days post-randomization)
Satisfaction: infusion
Time Frame: Post-CT assessment (approximately +5 days post-randomization)
self-report slider scale rating; range = 0-100; high score=better rating
Post-CT assessment (approximately +5 days post-randomization)
Future likelihood of use: infusion
Time Frame: Post-CT assessment (approximately +5 days post-randomization)
self-report slider scale rating; range = 0-100; high score=better rating
Post-CT assessment (approximately +5 days post-randomization)
Ease of use: Cognitive Training
Time Frame: Post-CT assessment (approximately +5 days post-randomization)
self-report slider scale rating; range = 0-100; high score=better rating
Post-CT assessment (approximately +5 days post-randomization)
Helpfulness: Cognitive Training
Time Frame: Post-CT assessment (approximately +5 days post-randomization)
self-report slider scale rating; range = 0-100; high score=better rating
Post-CT assessment (approximately +5 days post-randomization)
Satisfaction: Cognitive Training
Time Frame: Post-CT assessment (approximately +5 days post-randomization)
self-report slider scale rating; range = 0-100; high score=better rating
Post-CT assessment (approximately +5 days post-randomization)
Future likelihood of use: Cognitive Training
Time Frame: Post-CT assessment (approximately +5 days post-randomization)
self-report slider scale rating; range = 0-100; high score=better rating
Post-CT assessment (approximately +5 days post-randomization)
PROMIS Pain Intensity score
Time Frame: 24 hrs post-randomization
PROMIS Pain Intensity Short Form scale T-score (range=0-100; higher score=worse pain)
24 hrs post-randomization
PROMIS Pain Intensity score
Time Frame: Post-CT assessment (approximately +5 days post-randomization)
PROMIS Pain Intensity Short Form scale T-score (range=0-100; higher score=worse pain)
Post-CT assessment (approximately +5 days post-randomization)
PROMIS Neuropathic Pain Quality
Time Frame: 24 hrs post-randomization
PROMIS Neuropathic Pain Quality scale T-score (range=0-100; higher score=worse pain)
24 hrs post-randomization
PROMIS Neuropathic Pain Quality
Time Frame: Post-CT assessment (approximately +5 days post-randomization)
PROMIS Neuropathic Pain Quality scale T-score (range=0-100; higher score=worse pain)
Post-CT assessment (approximately +5 days post-randomization)
PROMIS Nociceptive Pain Quality
Time Frame: 24 hrs post-randomization
PROMIS Nociceptive Pain Quality scale T-score (range=0-100; higher score=worse pain)
24 hrs post-randomization
PROMIS Nociceptive Pain Quality
Time Frame: Post-CT assessment (approximately +5 days post-randomization)
PROMIS Nociceptive Pain Quality scale T-score (range=0-100; higher score=worse pain)
Post-CT assessment (approximately +5 days post-randomization)

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

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rebecca B Price, PhD, University of Pittsburgh

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.
March 15, 2021

Primary Completion (Estimated)

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.
December 2, 2026

Study Completion (Estimated)

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.
December 2, 2026

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).
October 1, 2020

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.
October 1, 2020

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.
October 8, 2020

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.
March 24, 2026

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.
March 19, 2026

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.
March 1, 2026

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 2)
  • R01MH124983 (U.S. NIH Grant/Contract)

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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