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Ketamine + Cognitive Training for Suicidality in the Medical Setting

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: NCT04578938
Recruitment Status : Enrolling by invitation
First Posted : October 8, 2020
Last Update Posted : August 10, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
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 : 200 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
Actual Study Start Date : March 15, 2021
Estimated Primary Completion Date : March 2, 2025
Estimated Study Completion Date : March 2, 2026

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

Active Comparator: No-infusion (TAU) + Cognitive Training Behavioral: Cognitive training
8 sessions of computer-based cognitive training

Sham Comparator: No-infusion (TAU) + Sham Training Behavioral: Sham Training
8 sessions of computer-based sham training




Primary Outcome Measures :
  1. Scale for Suicide Ideation [ Time Frame: infusion +24 hours (1 day) ]
    suicidal ideation/thoughts; range 0-38; high score=worse outcome

  2. Scale for Suicide Ideation [ Time Frame: infusion +5 days (4 days) ]
    suicidal ideation/thoughts; range 0-38; high score=worse outcome

  3. Scale for Suicide Ideation [ Time Frame: infusion +12 days (7 days) ]
    suicidal ideation/thoughts; range 0-38; high score=worse outcome

  4. Scale for Suicide Ideation [ Time Frame: infusion +1 month (2 weeks) ]
    suicidal ideation/thoughts; range 0-38; high score=worse outcome

  5. Scale for Suicide Ideation [ Time Frame: infusion +3 months (2 months) ]
    suicidal ideation/thoughts; range 0-38; high score=worse outcome

  6. Scale for Suicide Ideation [ Time Frame: infusion +6 months (3 months) ]
    suicidal ideation/thoughts; range 0-38; high score=worse outcome

  7. Scale for Suicide Ideation [ Time Frame: infusion +9 months (3 months) ]
    suicidal ideation/thoughts; range 0-38; high score=worse outcome

  8. Scale for Suicide Ideation [ Time Frame: infusion +12 months (3 months) ]
    suicidal ideation/thoughts; range 0-38; high score=worse outcome

  9. Suicidal behaviors: medical chart review [ Time Frame: infusion +12 months (12 months) ]
    # of patients with occurrence of any suicidal act (derived from medical chart) including: re-attempt, re-hospitalization for suicidality, or completed suicide

  10. Suicidal behaviors: Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: infusion +12 months (12 months) ]
    # of patients with 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

  11. Montgomery Asberg Depression Rating Scale [ Time Frame: infusion +24 hours (1 day) ]
    depression severity; range 0-60; high score=worse outcome

  12. Montgomery Asberg Depression Rating Scale [ Time Frame: infusion +5 days (4 days) ]
    depression severity; range 0-60; high score=worse outcome

  13. Montgomery Asberg Depression Rating Scale [ Time Frame: infusion +12 days (7 days) ]
    depression severity; range 0-60; high score=worse outcome

  14. Montgomery Asberg Depression Rating Scale [ Time Frame: infusion +1 month (1 week) ]
    depression severity; range 0-60; high score=worse outcome

  15. Montgomery Asberg Depression Rating Scale [ Time Frame: infusion +3 months (1 week) ]
    depression severity; range 0-60; high score=worse outcome

  16. Montgomery Asberg Depression Rating Scale [ Time Frame: infusion +6 months (1 week) ]
    depression severity; range 0-60; high score=worse outcome

  17. Montgomery Asberg Depression Rating Scale [ Time Frame: infusion +9 months (1 week) ]
    depression severity; range 0-60; high score=worse outcome

  18. Montgomery Asberg Depression Rating Scale [ Time Frame: infusion +12 months (1 week) ]
    depression severity; range 0-60; high score=worse outcome


Secondary 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

  7. Adult Suicide Ideation Questionnaire [ Time Frame: infusion +9 months (3 months) ]
    suicidal ideation/thoughts; range 0-150; high score=worse outcome

  8. Quick Inventory of Depressive Symptoms [ Time Frame: infusion +24 hours (1 day) ]
    Self-reported depression (range: 0-27; higher scores = worse outcome)

  9. Quick Inventory of Depressive Symptoms [ Time Frame: infusion +5 days (4 days) ]
    Self-reported depression (range: 0-27; higher scores = worse outcome)

  10. Quick Inventory of Depressive Symptoms [ Time Frame: infusion +12 days (7 days) ]
    Self-reported depression (range: 0-27; higher scores = worse outcome)

  11. Quick Inventory of Depressive Symptoms [ Time Frame: infusion +1 month (1 week) ]
    Self-reported depression (range: 0-27; higher scores = worse outcome)

  12. Quick Inventory of Depressive Symptoms [ Time Frame: infusion +3 months (1 week) ]
    Self-reported depression (range: 0-27; higher scores = worse outcome)

  13. Quick Inventory of Depressive Symptoms [ Time Frame: infusion +6 months (1 week) ]
    Self-reported depression (range: 0-27; higher scores = worse outcome)

  14. Quick Inventory of Depressive Symptoms [ Time Frame: infusion +9 months (1 week) ]
    Self-reported depression (range: 0-27; higher scores = worse outcome)

  15. Quick Inventory of Depressive Symptoms [ Time Frame: infusion +12 months (1 week) ]
    Self-reported depression (range: 0-27; higher scores = worse outcome)


Other Outcome Measures:
  1. Implicit Association Test [ Time Frame: infusion +24 hours (1 day) ]
    performance-based "target engagement" measure of suicidal cognition; range = -inf-inf; high score=worse outcome

  2. Implicit Association Test [ Time Frame: infusion +5 days (4 days) ]
    performance-based "target engagement" measure of suicidal cognition; range = -inf-inf; high score=worse outcome

  3. Implicit Association Test [ Time Frame: infusion +12 days (7 days) ]
    performance-based "target engagement" measure of suicidal cognition; range = -inf-inf; high score=worse outcome

  4. Implicit Association Test [ Time Frame: infusion +1 month (2 weeks) ]
    performance-based "target engagement" measure of suicidal cognition; range = -inf-inf; high score=worse outcome

  5. Implicit Association Test [ Time Frame: infusion +3 month (2 months) ]
    performance-based "target engagement" measure of suicidal cognition; range = -inf-inf; high score=worse outcome

  6. Implicit Association Test [ Time Frame: infusion +6 month (3 months) ]
    performance-based "target engagement" measure of suicidal cognition; range = -inf-inf; high score=worse outcome

  7. Implicit Association Test [ Time Frame: infusion +9 month (3 months) ]
    performance-based "target engagement" measure of suicidal cognition; range = -inf-inf; high score=worse outcome

  8. Implicit Association Test [ Time Frame: infusion +12 month (3 months) ]
    performance-based "target engagement" measure of suicidal cognition; range = -inf-inf; high score=worse outcome



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 who receive ketamine will:

  1. be between the ages of 18 and 65 years
  2. be a medical inpatient referred for psychiatric consultation/liaison due to suicidality and determined by psychiatric C/L to require inpatient psychiatric hospitalization
  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, mania, delirium, or dementia, or a diagnosis of developmental disorder with significant language and/or intellectual impairment
  2. Mini-Mental State Exam (MMSE) < 23
  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 6 months 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. 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
  10. Arrested individuals brought in by the legal system for medical stabilization

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): NCT04578938


Locations
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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Rebecca Price
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Rebecca B Price, PhD University of Pittsburgh
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Responsible Party: Rebecca Price, Associate Professor of Psychiatry and Psychology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04578938    
Other Study ID Numbers: MOD19100041-005
R01MH124983 ( U.S. NIH Grant/Contract )
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: August 10, 2021
Last Verified: August 2021
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