Ketamine + Cognitive Training for Suicidality in the Medical Setting

Suicide, Attempted Clinical Trial

Official title:

Ketamine + Cognitive Training for Suicidality in the Medical Setting

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04578938
• Other study ID #: STUDY19100041 (Part 2)
• Secondary ID: R01MH124983
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: March 15, 2021
• Est. completion date: March 2, 2026

Study information

• Verified date: October 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: March 2, 2026
• Est. primary completion date: March 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Participants who receive ketamine will:

1. be between the ages of 18 and 65 years

2. be a medical inpatient referred for psychiatric consultation/liaison due to suicidality and determined by psychiatric C/L to require inpatient psychiatric hospitalization

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

Related Conditions & MeSH terms

• Suicide
• Suicide, Attempted

Intervention

Drug:
• Intravenous ketamine
Single subanesthetic infusion of ketamine (0.5mg/kg)

Behavioral:
• Cognitive training
8 sessions of computer-based cognitive training
• Sham Training
8 sessions of computer-based sham training

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Rebecca Price	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Implicit Association Test	performance-based "target engagement" measure of suicidal cognition; range = -inf-inf; high score=worse outcome	Trajectories from 24hrs through 1 week
Other	Implicit Association Test	performance-based "target engagement" measure of suicidal cognition; range = -inf-inf; high score=worse outcome	Trajectories from 1 week through 12 months
Other	Acceptability: infusion	self-report slider scale rating; range = 0-100; high score=better rating	Post-CT assessment (approximately +5 days post-randomization)
Other	Satisfaction: infusion	self-report slider scale rating; range = 0-100; high score=better rating	Post-CT assessment (approximately +5 days post-randomization)
Other	Future likelihood of use: infusion	self-report slider scale rating; range = 0-100; high score=better rating	Post-CT assessment (approximately +5 days post-randomization)
Other	Ease of use: Cognitive Training	self-report slider scale rating; range = 0-100; high score=better rating	Post-CT assessment (approximately +5 days post-randomization)
Other	Helpfulness: Cognitive Training	self-report slider scale rating; range = 0-100; high score=better rating	Post-CT assessment (approximately +5 days post-randomization)
Other	Satisfaction: Cognitive Training	self-report slider scale rating; range = 0-100; high score=better rating	Post-CT assessment (approximately +5 days post-randomization)
Other	Future likelihood of use: Cognitive Training	self-report slider scale rating; range = 0-100; high score=better rating	Post-CT assessment (approximately +5 days post-randomization)
Primary	Scale for Suicide Ideation	suicidal ideation/thoughts; range 0-38; high score=worse outcome	Trajectories from 24hrs through 1 month
Primary	Montgomery Asberg Depression Rating Scale	depression severity; range 0-60; high score=worse outcome	Trajectories from 24hrs through 1 month
Primary	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	Adult Suicide Ideation Questionnaire	suicidal ideation/thoughts; range 0-150; high score=worse outcome	Trajectories from 24hrs through 12 months
Secondary	Quick Inventory of Depressive Symptoms	Self-reported depression (range: 0-27; higher scores = worse outcome)	Trajectories from 24hrs through 12 months
Secondary	Scale for Suicide Ideation	suicidal ideation/thoughts; range 0-38; high score=worse outcome	Trajectories from 1 month through 12 months
Secondary	Montgomery Asberg Depression Rating Scale	depression severity; range 0-60; high score=worse outcome	Trajectories from 1 month through 12 months