Ketamine + Cognitive Training for Suicidality in the Medical Setting

NCT04578938 | Active Not Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: STUDY19100041 (Part 2)R01MH124983
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide, Attempted

Outcome Measures

Primary Outcomes (3)

• Scale for Suicide Ideation

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

  Trajectories from 24hrs through 1 month

• Montgomery Asberg Depression Rating Scale

  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)

  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 Outcomes (4)

• Adult Suicide Ideation Questionnaire

  Trajectories from 24hrs through 12 months

• Quick Inventory of Depressive Symptoms

  Trajectories from 24hrs through 12 months

• Scale for Suicide Ideation

  Trajectories from 1 month through 12 months

• Montgomery Asberg Depression Rating Scale

  Trajectories from 1 month through 12 months

Other Outcomes (15)

• Implicit Association Test

  Trajectories from 24hrs through 1 week

• Implicit Association Test

  Trajectories from 1 week through 12 months

• Acceptability: infusion

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

Study Arms (4)

Ketamine + Cognitive Training

EXPERIMENTAL

Drug: Intravenous ketamine; Behavioral: Cognitive training

Ketamine + Sham Training

SHAM COMPARATOR

Drug: Intravenous ketamine; Behavioral: Sham Training

No-infusion (TAU) + Cognitive Training

ACTIVE COMPARATOR

Behavioral: Cognitive training

No-infusion (TAU) + Sham Training

SHAM COMPARATOR

Behavioral: Sham Training

Interventions

Intravenous ketamine DRUG

Single subanesthetic infusion of ketamine (0.5mg/kg)

Ketamine + Cognitive Training; Ketamine + Sham Training

Cognitive training BEHAVIORAL

8 sessions of computer-based cognitive training

Ketamine + Cognitive Training; No-infusion (TAU) + Cognitive Training

Sham Training BEHAVIORAL

8 sessions of computer-based sham training

Ketamine + Sham Training; No-infusion (TAU) + Sham Training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rebecca Price: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Suicide, Attempted

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Rebecca B Price, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Psychiatry and Psychology

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 8, 2020
• Study Start: March 15, 2021
• Primary Completion (Estimated): December 2, 2026
• Study Completion (Estimated): December 2, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)