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TerminatedPhase 4Results posted

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

NCT04154150 · Rebecca Price

Closed to entry
Status
Not accepting participants
Phase 4
Phase
16
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Montgomery Asberg Depression Rating Scale

    Measured over infusion +24 hours

  • Montgomery Asberg Depression Rating Scale

    Measured over infusion +5 days

  • Montgomery Asberg Depression Rating Scale

    Measured over infusion +12 days

  • Montgomery Asberg Depression Rating Scale

    Measured over infusion +1 month

  • Montgomery Asberg Depression Rating Scale

    Measured over infusion +3 months

  • Montgomery Asberg Depression Rating Scale

    Measured over infusion +6 months

  • Adult Suicide Ideation Questionnaire (Past Day Version)

    Measured over infusion +24 hours

  • Adult Suicide Ideation Questionnaire (Past Day Version)

    Measured over infusion +5 days

  • Adult Suicide Ideation Questionnaire (Past Day Version)

    Measured over infusion +12 days

  • Adult Suicide Ideation Questionnaire

    Measured over infusion +1 month

  • Adult Suicide Ideation Questionnaire

    Measured over infusion +3 months

  • Adult Suicide Ideation Questionnaire

    Measured over infusion +6 months

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
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

Where

1 study site

FacilityCityRegionCountry
University of PittsburghPittsburghPennsylvaniaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04154150 on ClinicalTrials.gov →

Last updated in the registry 2024-07-22. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits