Suicide, Attempted
Conditions
Brief 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.
Detailed description
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. 03/19/26: Edit to upper age limit made to correct a previous data entry error and align with IRB-approved protocol.
Interventions
Single subanesthetic infusion of ketamine (0.5mg/kg)
BEHAVIORALCognitive training
8 sessions of computer-based cognitive training
BEHAVIORALSham Training
8 sessions of computer-based sham training
Sponsors
Rebecca Price
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scale for Suicide Ideation | Trajectories from 24hrs through 1 month | suicidal ideation/thoughts; range 0-38; high score=worse outcome |
| Montgomery Asberg Depression Rating Scale | Trajectories from 24hrs through 1 month | depression severity; range 0-60; high score=worse outcome |
| Suicidal behaviors: medical chart review and Columbia Suicide Severity Rating Scale (CSSRS) | Trajectories from 24hrs through 12 months | composite measure of # unique occurrences of any suicidal outcome (recorded via either measure) including: re-attempt, re-hospitalization for suicidality, suicide behaviors, or completed suicide |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adult Suicide Ideation Questionnaire | Trajectories from 24hrs through 12 months | suicidal ideation/thoughts; range 0-150; high score=worse outcome |
| Quick Inventory of Depressive Symptoms | Trajectories from 24hrs through 12 months | Self-reported depression (range: 0-27; higher scores = worse outcome) |
| Scale for Suicide Ideation | Trajectories from 1 month through 12 months | suicidal ideation/thoughts; range 0-38; high score=worse outcome |
| Montgomery Asberg Depression Rating Scale | Trajectories from 1 month through 12 months | depression severity; range 0-60; high score=worse outcome |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRebecca B Price, PhD
University of Pittsburgh
Outcome results
None listed