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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-19

Study Completion Date

2022-03-15

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: 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.

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

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 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No