Ketamine + Cognitive Training for Suicidality in the Medical Setting

Rebecca Price

Status and phase: Active, not recruiting; Phase 4

Conditions: Suicide, Attempted

Treatments: Behavioral: Sham Training; Drug: Intravenous ketamine; Behavioral: Cognitive training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04578938

STUDY19100041 (Part 2)

R01MH124983 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 4 patient groups

Ketamine + Cognitive Training

Experimental group

Treatment:

Behavioral: Cognitive training

Drug: Intravenous ketamine

Ketamine + Sham Training

Sham Comparator group

Treatment:

Drug: Intravenous ketamine

Behavioral: Sham Training

No-infusion (TAU) + Cognitive Training

Active Comparator group

Treatment:

Behavioral: Cognitive training

No-infusion (TAU) + Sham Training

Sham Comparator group

Treatment:

Behavioral: Sham Training