Clinical trial NCT04154150: Ketamine + Cognitive Training for Suicidality in the Medical Setting: Pilot
Official title: Ketamine + Cognitive Training for Suicidality in the Medical Setting: Pilot
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Suicide, Attempted
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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: In the course of this pilot study, both the primary and secondary outcome measures were supplemented to provide additional, complementary information on the clinical effects of the study interventions, based on confirmation (through study team experience) of the feasibility of acquiring such additional information in the context of our study population, setting, and design.

Eligibility criteria: 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

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale
timeFrame: infusion +24 hours
measure: Montgomery Asberg Depression Rating Scale
timeFrame: infusion +5 days
measure: Montgomery Asberg Depression Rating Scale
timeFrame: infusion +12 days
measure: Montgomery Asberg Depression Rating Scale
timeFrame: infusion +1 month
measure: Montgomery Asberg Depression Rating Scale
timeFrame: infusion +3 months
measure: Montgomery Asberg Depression Rating Scale
timeFrame: infusion +6 months
measure: Adult Suicide Ideation Questionnaire (Past Day Version)
timeFrame: infusion +24 hours
measure: Adult Suicide Ideation Questionnaire (Past Day Version)
timeFrame: infusion +5 days
measure: Adult Suicide Ideation Questionnaire (Past Day Version)
timeFrame: infusion +12 days
measure: Adult Suicide Ideation Questionnaire
timeFrame: infusion +1 month
measure: Adult Suicide Ideation Questionnaire
timeFrame: infusion +3 months
measure: Adult Suicide Ideation Questionnaire
timeFrame: infusion +6 months
Secondary outcomes:
measure: Number of Participants With Occurrence of Suicidal Behaviors Per Medical Chart Review
timeFrame: infusion +6 months
measure: Number of Participants Reporting Suicidal Behaviors Per the Columbia Suicide Severity Rating Scale (CSSRS)
timeFrame: infusion +6 months
measure: Quick Inventory of Depressive Symptoms
timeFrame: infusion +24 hours
measure: Quick Inventory of Depressive Symptoms
timeFrame: infusion +5 days
measure: Quick Inventory of Depressive Symptoms
timeFrame: infusion +12 days
measure: Quick Inventory of Depressive Symptoms
timeFrame: infusion +1 month
measure: Quick Inventory of Depressive Symptoms
timeFrame: infusion +3 months
measure: Quick Inventory of Depressive Symptoms
timeFrame: infusion +6 months
measure: Scale for Suicide Ideation
timeFrame: infusion +24 hours
measure: Scale for Suicide Ideation
timeFrame: infusion +5 days
measure: Scale for Suicide Ideation
timeFrame: infusion +12 days
measure: Scale for Suicide Ideation
timeFrame: infusion +1 month
measure: Scale for Suicide Ideation
timeFrame: infusion +3 months
measure: Scale for Suicide Ideation
timeFrame: infusion +6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
References: