Ketamine + Cognitive Training for Suicidality in the Medical Setting (NCT04578938) | Clinical Trial Compass
Active ā Not RecruitingPhase 4
Ketamine + Cognitive Training for Suicidality in the Medical Setting
United States200 participantsStarted 2021-03-15
Plain-language 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.
Who can participate
Age range18 Years ā 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. be between the ages of 18 and 70 years
ā. 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)
ā. possess a level of judgment and understanding sufficient to agree to all procedures required by the protocol and must sign an informed consent document
ā. 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
ā. 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
ā. Mini-Mental State Exam (MMSE) \< 21
ā. Current pregnancy or breastfeeding
ā. 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
ā. Past intolerance or hypersensitivity to ketamine or esketamine
ā. Patients taking St John's Wort
ā. Patients who have received ECT in the past 1 month prior to intake
What they're measuring
1
Scale for Suicide Ideation
Timeframe: Trajectories from 24hrs through 1 month
2
Montgomery Asberg Depression Rating Scale
Timeframe: Trajectories from 24hrs through 1 month
3
Suicidal behaviors: medical chart review and Columbia Suicide Severity Rating Scale (CSSRS)
Timeframe: Trajectories from 24hrs through 12 months
. 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