Ketamine + Cognitive Training for Suicidality in the Medical Setting: Pilot

Suicide, Attempted Clinical Trial

Official title:

Ketamine + Cognitive Training for Suicidality in the Medical Setting: Pilot

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04154150
• Other study ID #: STUDY19100041 (Part 1)
• Status: Terminated
• Phase: Phase 4
• Start date: December 19, 2019
• Est. completion date: March 15, 2022

Study information

• Verified date: December 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Suicide
• Suicide, Attempted

Intervention

Drug:
• Intravenous ketamine
Single subanesthetic infusion of ketamine (0.5mg/kg)

Behavioral:
• Cognitive training
8 sessions of computer-based cognitive training
• Sham Training
8 sessions of computer-based sham training

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rebecca Price

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery Asberg Depression Rating Scale	depression severity; range 0-60; high score=worse outcome	infusion +24 hours
Primary	Montgomery Asberg Depression Rating Scale	depression severity; range 0-60; high score=worse outcome	infusion +5 days
Primary	Montgomery Asberg Depression Rating Scale	depression severity; range 0-60; high score=worse outcome	infusion +12 days
Primary	Montgomery Asberg Depression Rating Scale	depression severity; range 0-60; high score=worse outcome	infusion +1 month
Primary	Montgomery Asberg Depression Rating Scale	depression severity; range 0-60; high score=worse outcome	infusion +3 months
Primary	Montgomery Asberg Depression Rating Scale	depression severity; range 0-60; high score=worse outcome	infusion +6 months
Primary	Adult Suicide Ideation Questionnaire (Past Day Version)	suicidal ideation/thoughts; range 0-150; high score=worse outcome	infusion +24 hours
Primary	Adult Suicide Ideation Questionnaire (Past Day Version)	suicidal ideation/thoughts; range 0-150; high score=worse outcome	infusion +5 days
Primary	Adult Suicide Ideation Questionnaire (Past Day Version)	suicidal ideation/thoughts; range 0-150; high score=worse outcome	infusion +12 days
Primary	Adult Suicide Ideation Questionnaire	suicidal ideation/thoughts; range 0-150; high score=worse outcome	infusion +1 month
Primary	Adult Suicide Ideation Questionnaire	suicidal ideation/thoughts; range 0-150; high score=worse outcome	infusion +3 months
Primary	Adult Suicide Ideation Questionnaire	suicidal ideation/thoughts; range 0-150; high score=worse outcome	infusion +6 months
Secondary	Number of Participants With Occurrence of Suicidal Behaviors Per Medical Chart Review	Number of participants with occurrence of any suicidal act (derived from medical chart) including: re-attempt, re-hospitalization for suicidality, or completed suicide	infusion +6 months
Secondary	Number of Participants Reporting Suicidal Behaviors Per the Columbia Suicide Severity Rating Scale (CSSRS)	Number of participants with occurrence of any suicidal act (derived from Columbia Suicide Severity Rating Scale interview; each of the following items was scored yes/no for the period since last assessment: re-attempt, re-hospitalization for suicidality, or completed suicide. Analyzed outcome measure is # of participants with 1 or more 'yes' responses.	infusion +6 months
Secondary	Quick Inventory of Depressive Symptoms	Self-reported depression (range: 0-27; higher scores = worse outcome)	infusion +24 hours
Secondary	Quick Inventory of Depressive Symptoms	Self-reported depression (range: 0-27; higher scores = worse outcome)	infusion +5 days
Secondary	Quick Inventory of Depressive Symptoms	Self-reported depression (range: 0-27; higher scores = worse outcome)	infusion +12 days
Secondary	Quick Inventory of Depressive Symptoms	Self-reported depression (range: 0-27; higher scores = worse outcome)	infusion +1 month
Secondary	Quick Inventory of Depressive Symptoms	Self-reported depression (range: 0-27; higher scores = worse outcome)	infusion +3 months
Secondary	Quick Inventory of Depressive Symptoms	Self-reported depression (range: 0-27; higher scores = worse outcome)	infusion +6 months
Secondary	Scale for Suicide Ideation	suicidal ideation/thoughts; range 0-38; high score=worse outcome	infusion +24 hours
Secondary	Scale for Suicide Ideation	suicidal ideation/thoughts; range 0-38; high score=worse outcome	infusion +5 days
Secondary	Scale for Suicide Ideation	suicidal ideation/thoughts; range 0-38; high score=worse outcome	infusion +12 days
Secondary	Scale for Suicide Ideation	suicidal ideation/thoughts; range 0-38; high score=worse outcome	infusion +1 month
Secondary	Scale for Suicide Ideation	suicidal ideation/thoughts; range 0-38; high score=worse outcome	infusion +3 months
Secondary	Scale for Suicide Ideation	suicidal ideation/thoughts; range 0-38; high score=worse outcome	infusion +6 months