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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154150
Recruitment Status : Enrolling by invitation
First Posted : November 6, 2019
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Rebecca Price, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Suicide, Attempted Drug: Intravenous ketamine Behavioral: Cognitive training Behavioral: Sham Training Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ketamine + Cognitive Training for Suicidality in the Medical Setting: Pilot
Actual Study Start Date : December 19, 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide
Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine + Cognitive Training Drug: Intravenous ketamine
Single subanesthetic infusion of ketamine (0.5mg/kg)

Behavioral: Cognitive training
8 sessions of computer-based cognitive training

Sham Comparator: Ketamine + Sham Training Drug: Intravenous ketamine
Single subanesthetic infusion of ketamine (0.5mg/kg)

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




Primary Outcome Measures :
  1. Adult Suicide Ideation Questionnaire [ Time Frame: infusion +24 hours (1 day) ]
    suicidal ideation/thoughts; range 0-150; high score=worse outcome

  2. Adult Suicide Ideation Questionnaire [ Time Frame: infusion +5 days (4 days) ]
    suicidal ideation/thoughts; range 0-150; high score=worse outcome

  3. Adult Suicide Ideation Questionnaire [ Time Frame: infusion +12 days (7 days) ]
    suicidal ideation/thoughts; range 0-150; high score=worse outcome

  4. Adult Suicide Ideation Questionnaire [ Time Frame: infusion +1 month (2 weeks) ]
    suicidal ideation/thoughts; range 0-150; high score=worse outcome

  5. Adult Suicide Ideation Questionnaire [ Time Frame: infusion +3 months (2 months) ]
    suicidal ideation/thoughts; range 0-150; high score=worse outcome

  6. Adult Suicide Ideation Questionnaire [ Time Frame: infusion +6 months (3 months) ]
    suicidal ideation/thoughts; range 0-150; high score=worse outcome


Secondary Outcome Measures :
  1. Suicidal behaviors: medical chart review [ Time Frame: infusion +6 months (6 months) ]
    Occurrence of any suicidal act (derived from medical chart) including: re-attempt, re-hospitalization for suicidality, or completed suicide

  2. Suicidal behaviors: Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: infusion +6 months (6 months) ]
    Occurrence of any suicidal act (derived from CSSRS, each item is scored yes/no for period since last assessment) including: re-attempt, re-hospitalization for suicidality, or completed suicide



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154150


Locations
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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Rebecca Price
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Responsible Party: Rebecca Price, Assistant Professor of Psychiatry and Psychology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04154150    
Other Study ID Numbers: STUDY19100041
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Suicide
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action