Ketamine + Cognitive Training for Suicidality in the Medical Setting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2026-12-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Suicide, Attempted

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ketamine + Cognitive Training

Group Type EXPERIMENTAL

Intravenous ketamine

Intervention Type DRUG

Single subanesthetic infusion of ketamine (0.5mg/kg)

Cognitive training

Intervention Type BEHAVIORAL

8 sessions of computer-based cognitive training

Ketamine + Sham Training

Group Type SHAM_COMPARATOR

Intravenous ketamine

Intervention Type DRUG

Single subanesthetic infusion of ketamine (0.5mg/kg)

Sham Training

Intervention Type BEHAVIORAL

8 sessions of computer-based sham training

No-infusion (TAU) + Cognitive Training

Group Type ACTIVE_COMPARATOR

Cognitive training

Intervention Type BEHAVIORAL

8 sessions of computer-based cognitive training

No-infusion (TAU) + Sham Training

Group Type SHAM_COMPARATOR

Sham Training

Intervention Type BEHAVIORAL

8 sessions of computer-based sham training

Interventions

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Intravenous ketamine

Single subanesthetic infusion of ketamine (0.5mg/kg)

Intervention Type DRUG

Cognitive training

8 sessions of computer-based cognitive training

Intervention Type BEHAVIORAL

Sham Training

8 sessions of computer-based sham training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No