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Active, Not Recruiting

NCT Number: NCT04578938

Ketamine + Cognitive Training for Suicidality in the Medical Setting

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Suicide, Attempted Behavior Behavioral Symptoms Self-Injurious Behavior Suicide

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants who receive ketamine will:

  • be between the ages of 18 and 70 years
  • 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)
  • 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

Treatment and study plan

Intravenous ketamine

Drug

Single subanesthetic infusion of ketamine (0.5mg/kg)

Cognitive training

Behavioral

8 sessions of computer-based cognitive training

Sham Training

Behavioral

8 sessions of computer-based sham training

Primary outcomes

  1. Scale for Suicide Ideation

    Time frame: Trajectories from 24hrs through 1 month

    suicidal ideation/thoughts; range 0-38; high score=worse outcome

  2. Montgomery Asberg Depression Rating Scale

    Time frame: Trajectories from 24hrs through 1 month

    depression severity; range 0-60; high score=worse outcome

  3. 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

Secondary outcomes

  1. Adult Suicide Ideation Questionnaire

    Time frame: Trajectories from 24hrs through 12 months

    suicidal ideation/thoughts; range 0-150; high score=worse outcome

  2. Quick Inventory of Depressive Symptoms

    Time frame: Trajectories from 24hrs through 12 months

    Self-reported depression (range: 0-27; higher scores = worse outcome)

  3. Scale for Suicide Ideation

    Time frame: Trajectories from 1 month through 12 months

    suicidal ideation/thoughts; range 0-38; high score=worse outcome

  4. Montgomery Asberg Depression Rating Scale

    Time frame: Trajectories from 1 month through 12 months

    depression severity; range 0-60; high score=worse outcome

Other outcomes

  1. 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

  2. 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

  3. Acceptability: infusion

    Time frame: Post-CT assessment (approximately +5 days post-randomization)

    self-report slider scale rating; range = 0-100; high score=better rating

  4. Satisfaction: infusion

    Time frame: Post-CT assessment (approximately +5 days post-randomization)

    self-report slider scale rating; range = 0-100; high score=better rating

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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)

  11. 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)

  12. PROMIS Neuropathic Pain Quality

    Time frame: 24 hrs post-randomization

    PROMIS Neuropathic Pain Quality scale T-score (range=0-100; higher score=worse pain)

  13. 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)

  14. PROMIS Nociceptive Pain Quality

    Time frame: 24 hrs post-randomization

    PROMIS Nociceptive Pain Quality scale T-score (range=0-100; higher score=worse pain)

  15. 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)

Sponsors and collaborators

Lead sponsor

Rebecca Price

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Oct 8, 2020
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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