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

NCT04154150 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: STUDY19100041 (Part 1)
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide, Attempted

Outcome Measures

Primary Outcomes (12)

• Montgomery Asberg Depression Rating Scale

  depression severity; range 0-60; high score=worse outcome

  infusion +24 hours

• Montgomery Asberg Depression Rating Scale

  depression severity; range 0-60; high score=worse outcome

  infusion +5 days

• Montgomery Asberg Depression Rating Scale

  depression severity; range 0-60; high score=worse outcome

  infusion +12 days

• Montgomery Asberg Depression Rating Scale

  depression severity; range 0-60; high score=worse outcome

  infusion +1 month

• Montgomery Asberg Depression Rating Scale

  depression severity; range 0-60; high score=worse outcome

  infusion +3 months

• Montgomery Asberg Depression Rating Scale

  depression severity; range 0-60; high score=worse outcome

  infusion +6 months

• Adult Suicide Ideation Questionnaire (Past Day Version)

  suicidal ideation/thoughts; range 0-150; high score=worse outcome

  infusion +24 hours

• Adult Suicide Ideation Questionnaire (Past Day Version)

  suicidal ideation/thoughts; range 0-150; high score=worse outcome

  infusion +5 days

• Adult Suicide Ideation Questionnaire (Past Day Version)

  suicidal ideation/thoughts; range 0-150; high score=worse outcome

  infusion +12 days

• Adult Suicide Ideation Questionnaire

  suicidal ideation/thoughts; range 0-150; high score=worse outcome

  infusion +1 month

• Adult Suicide Ideation Questionnaire

  suicidal ideation/thoughts; range 0-150; high score=worse outcome

  infusion +3 months

• Adult Suicide Ideation Questionnaire

  suicidal ideation/thoughts; range 0-150; high score=worse outcome

  infusion +6 months

Secondary Outcomes (14)

• Number of Participants With Occurrence of Suicidal Behaviors Per Medical Chart Review

  infusion +6 months

• Number of Participants Reporting Suicidal Behaviors Per the Columbia Suicide Severity Rating Scale (CSSRS)

  infusion +6 months

• Quick Inventory of Depressive Symptoms

  infusion +24 hours

• Quick Inventory of Depressive Symptoms

  infusion +5 days

• Quick Inventory of Depressive Symptoms

  infusion +12 days

Study Arms (2)

Ketamine + Cognitive Training

EXPERIMENTAL

Drug: Intravenous ketamine; Behavioral: Cognitive training

Ketamine + Sham Training

SHAM COMPARATOR

Drug: Intravenous ketamine; Behavioral: Sham Training

Interventions

Intravenous ketamine DRUG

Single subanesthetic infusion of ketamine (0.5mg/kg)

Ketamine + Cognitive Training; Ketamine + Sham Training

Cognitive training BEHAVIORAL

8 sessions of computer-based cognitive training

Ketamine + Cognitive Training

Sham Training BEHAVIORAL

8 sessions of computer-based sham training

Ketamine + Sham Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will:
• be between the ages of 18 and 65 years
• be a medical inpatient referred for psychiatric consultation/liaison due to suicidality
• possess a level of judgment and understanding sufficient to agree to all procedures required by the protocol and must sign an informed consent document
• be deemed an appropriate and reasonable medical candidate for intravenous ketamine by a physician authorized to prescribe medication to the patient during inpatient hospitalization

You may not qualify if:

• Presence of current psychotic or autism spectrum disorder or current delirium
• Use of a Monoamine Oxidase Inhibitor (MAOI) within the previous 2 weeks
• Current pregnancy or breastfeeding
• Reading level \<5th grade as per WRAT-3 reading subtest
• Past intolerance or hypersensitivity to ketamine
• Patients taking any of the following medications: St John's Wort, theophylline, tramadol, metrizamide
• Patients who have received ECT in the past 6 months prior to intake
• Patients at risk for withdrawal related issues (e.g., delirium tremens, severe opiate withdrawal) or who present with substance-induced psychosis
• 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

Sponsors & Collaborators

• Rebecca Price: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Suicide, Attempted

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

Pilot study leading to small numbers of patients in each treatment arm. Descriptive statistics are reported without statistical analysis to directly compare groups, given the small number of patients within each group leading to low statistical power.

Results Point of Contact

• Title: Dr. Rebecca Price
• Organization: University of Pittsburgh

pricerb@upmc.edu

412-383-2150

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Psychiatry and Psychology

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 6, 2019
• Study Start: December 19, 2019
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: July 22, 2024
• Results First Posted: January 10, 2023

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)