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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH124983 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine + Cognitive Training | Experimental |
| |
| Ketamine + Sham Training | Sham Comparator |
| |
| No-infusion (TAU) + Cognitive Training | Active Comparator |
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| No-infusion (TAU) + Sham Training | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous ketamine | Drug | Single subanesthetic infusion of ketamine (0.5mg/kg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Scale for Suicide Ideation | suicidal ideation/thoughts; range 0-38; high score=worse outcome | Trajectories from 24hrs through 1 month |
| Montgomery Asberg Depression Rating Scale | depression severity; range 0-60; high score=worse outcome | Trajectories from 24hrs through 1 month |
| Suicidal behaviors: medical chart review and Columbia Suicide Severity Rating Scale (CSSRS) | 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 | Trajectories from 24hrs through 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adult Suicide Ideation Questionnaire | suicidal ideation/thoughts; range 0-150; high score=worse outcome | Trajectories from 24hrs through 12 months |
| Quick Inventory of Depressive Symptoms | Self-reported depression (range: 0-27; higher scores = worse outcome) |
| Measure | Description | Time Frame |
|---|---|---|
| Implicit Association Test | performance-based "target engagement" measure of suicidal cognition; range = -inf-inf; high score=worse outcome | Trajectories from 24hrs through 1 week |
| Implicit Association Test |
Inclusion Criteria:
Participants who receive ketamine will:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca B Price, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Term |
|---|---|
| D013406 | Suicide, Attempted |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Cognitive training | Behavioral | 8 sessions of computer-based cognitive training |
|
| Sham Training | Behavioral | 8 sessions of computer-based sham training |
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| Trajectories from 24hrs through 12 months |
| Scale for Suicide Ideation | suicidal ideation/thoughts; range 0-38; high score=worse outcome | Trajectories from 1 month through 12 months |
| Montgomery Asberg Depression Rating Scale | depression severity; range 0-60; high score=worse outcome | Trajectories from 1 month through 12 months |
performance-based "target engagement" measure of suicidal cognition; range = -inf-inf; high score=worse outcome
| Trajectories from 1 week through 12 months |
| Acceptability: infusion | self-report slider scale rating; range = 0-100; high score=better rating | Post-CT assessment (approximately +5 days post-randomization) |
| Satisfaction: infusion | self-report slider scale rating; range = 0-100; high score=better rating | Post-CT assessment (approximately +5 days post-randomization) |
| Future likelihood of use: infusion | self-report slider scale rating; range = 0-100; high score=better rating | Post-CT assessment (approximately +5 days post-randomization) |
| Ease of use: Cognitive Training | self-report slider scale rating; range = 0-100; high score=better rating | Post-CT assessment (approximately +5 days post-randomization) |
| Helpfulness: Cognitive Training | self-report slider scale rating; range = 0-100; high score=better rating | Post-CT assessment (approximately +5 days post-randomization) |
| Satisfaction: Cognitive Training | self-report slider scale rating; range = 0-100; high score=better rating | Post-CT assessment (approximately +5 days post-randomization) |
| Future likelihood of use: Cognitive Training | self-report slider scale rating; range = 0-100; high score=better rating | Post-CT assessment (approximately +5 days post-randomization) |
| PROMIS Pain Intensity score | PROMIS Pain Intensity Short Form scale T-score (range=0-100; higher score=worse pain) | 24 hrs post-randomization |
| PROMIS Pain Intensity score | PROMIS Pain Intensity Short Form scale T-score (range=0-100; higher score=worse pain) | Post-CT assessment (approximately +5 days post-randomization) |
| PROMIS Neuropathic Pain Quality | PROMIS Neuropathic Pain Quality scale T-score (range=0-100; higher score=worse pain) | 24 hrs post-randomization |
| PROMIS Neuropathic Pain Quality | PROMIS Neuropathic Pain Quality scale T-score (range=0-100; higher score=worse pain) | Post-CT assessment (approximately +5 days post-randomization) |
| PROMIS Nociceptive Pain Quality | PROMIS Nociceptive Pain Quality scale T-score (range=0-100; higher score=worse pain) | 24 hrs post-randomization |
| PROMIS Nociceptive Pain Quality | PROMIS Nociceptive Pain Quality scale T-score (range=0-100; higher score=worse pain) | Post-CT assessment (approximately +5 days post-randomization) |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |