Clinical trial NCT04578938: Ketamine + Cognitive Training for Suicidality in the Medical Setting
Official title: Ketamine + Cognitive Training for Suicidality in the Medical Setting
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Suicide, Attempted
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-10-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Scale for Suicide Ideation
timeFrame: Trajectories from 24hrs through 1 month
measure: Montgomery Asberg Depression Rating Scale
timeFrame: Trajectories from 24hrs through 1 month
measure: Suicidal behaviors: medical chart review and Columbia Suicide Severity Rating Scale (CSSRS)
timeFrame: Trajectories from 24hrs through 12 months
Secondary outcomes:
measure: Adult Suicide Ideation Questionnaire
timeFrame: Trajectories from 24hrs through 12 months
measure: Quick Inventory of Depressive Symptoms
timeFrame: Trajectories from 24hrs through 12 months
measure: Scale for Suicide Ideation
timeFrame: Trajectories from 1 month through 12 months
measure: Montgomery Asberg Depression Rating Scale
timeFrame: Trajectories from 1 month through 12 months
Other outcomes:
measure: Implicit Association Test
timeFrame: Trajectories from 24hrs through 1 week
measure: Implicit Association Test
timeFrame: Trajectories from 1 week through 12 months
measure: Acceptability: infusion
timeFrame: Post-CT assessment (approximately +5 days post-randomization)
measure: Satisfaction: infusion
timeFrame: Post-CT assessment (approximately +5 days post-randomization)
measure: Future likelihood of use: infusion
timeFrame: Post-CT assessment (approximately +5 days post-randomization)
measure: Ease of use: Cognitive Training
timeFrame: Post-CT assessment (approximately +5 days post-randomization)
measure: Helpfulness: Cognitive Training
timeFrame: Post-CT assessment (approximately +5 days post-randomization)
measure: Satisfaction: Cognitive Training
timeFrame: Post-CT assessment (approximately +5 days post-randomization)
measure: Future likelihood of use: Cognitive Training
timeFrame: Post-CT assessment (approximately +5 days post-randomization)
measure: PROMIS Pain Intensity score
timeFrame: 24 hrs post-randomization
measure: PROMIS Pain Intensity score
timeFrame: Post-CT assessment (approximately +5 days post-randomization)
measure: PROMIS Neuropathic Pain Quality
timeFrame: 24 hrs post-randomization
measure: PROMIS Neuropathic Pain Quality
timeFrame: Post-CT assessment (approximately +5 days post-randomization)
measure: PROMIS Nociceptive Pain Quality
timeFrame: 24 hrs post-randomization
measure: PROMIS Nociceptive Pain Quality
timeFrame: Post-CT assessment (approximately +5 days post-randomization)
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Rebecca B Price, PhD
role: PRINCIPAL_INVESTIGATOR
References: