Ketamine + Cognitive Training for Suicidality in the Medical Setting: Pilot

Rebecca Price

Status and phase: Terminated; Phase 4

Conditions: Suicide, Attempted

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04154150

STUDY19100041 (Part 1)

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: In the course of this pilot study, both the primary and secondary outcome measures were supplemented to provide additional, complementary information on the clinical effects of the study interventions, based on confirmation (through study team experience) of the feasibility of acquiring such additional information in the context of our study population, setting, and design.

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Participants will:

1. be between the ages of 18 and 65 years
2. be a medical inpatient referred for psychiatric consultation/liaison due to suicidality
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 psychotic or autism spectrum disorder or current delirium
2. Use of a Monoamine Oxidase Inhibitor (MAOI) within the previous 2 weeks
3. Current pregnancy or breastfeeding
4. Reading level <5th grade as per WRAT-3 reading subtest
5. Past intolerance or hypersensitivity to ketamine
6. Patients taking any of the following medications: St John's Wort, theophylline, tramadol, metrizamide
7. Patients who have received ECT in the past 6 months prior to intake
8. Patients at risk for withdrawal related issues (e.g., delirium tremens, severe opiate withdrawal) or who present with substance-induced psychosis
9. Patients who, based on expressed preference and/or home geographic location, are deemed by the Psychiatric Consultation/Liaison service to be likely to receive inpatient psychiatric hospitalization at an alternate location outside of Western Psychiatric Institute & Clinic

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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16 participants in 2 patient groups

Ketamine + Cognitive Training

Experimental group

Treatment:

Drug: Intravenous ketamine

Behavioral: Cognitive training

Ketamine + Sham Training

Sham Comparator group

Treatment:

Drug: Intravenous ketamine

Behavioral: Sham Training