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

• Sponsor: Rebecca Price (Other)
• Overall Status: Completed
• CT.gov ID: NCT04154150
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Actual Duration (Months): 26.8
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 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: Dec 19, 2019
• Actual Primary Completion Date: Mar 15, 2022
• Actual Study Completion Date: Mar 15, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Adult Suicide Ideation Questionnaire [infusion +24 hours (1 day)]

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

2. Montgomery Asberg Depression Rating Scale [infusion +24 hours (1 day)]

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

3. Montgomery Asberg Depression Rating Scale [infusion +5 days (4 days)]

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

4. Montgomery Asberg Depression Rating Scale [infusion +12 days (7 days)]

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

5. Montgomery Asberg Depression Rating Scale [infusion +1 month (1 week)]

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

6. Montgomery Asberg Depression Rating Scale [infusion +3 months (1 week)]

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

7. Montgomery Asberg Depression Rating Scale [infusion +6 months (1 week)]

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

8. Adult Suicide Ideation Questionnaire [infusion +5 days (4 days)]

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

9. Adult Suicide Ideation Questionnaire [infusion +12 days (7 days)]

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

10. Adult Suicide Ideation Questionnaire [infusion +1 month (2 weeks)]

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

11. Adult Suicide Ideation Questionnaire [infusion +3 months (2 months)]

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

12. Adult Suicide Ideation Questionnaire [infusion +6 months (3 months)]

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

Secondary Outcome Measures

1. Suicidal behaviors: medical chart review [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) [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

3. Quick Inventory of Depressive Symptoms [infusion +24 hours (1 day)]

   Self-reported depression (range: 0-27; higher scores = worse outcome)

4. Quick Inventory of Depressive Symptoms [infusion +5 days (4 days)]

   Self-reported depression (range: 0-27; higher scores = worse outcome)

5. Quick Inventory of Depressive Symptoms [infusion +12 days (7 days)]

   Self-reported depression (range: 0-27; higher scores = worse outcome)

6. Quick Inventory of Depressive Symptoms [infusion +1 month (1 week)]

   Self-reported depression (range: 0-27; higher scores = worse outcome)

7. Quick Inventory of Depressive Symptoms [infusion +3 months (1 week)]

   Self-reported depression (range: 0-27; higher scores = worse outcome)

8. Quick Inventory of Depressive Symptoms [infusion +6 months (1 week)]

   Self-reported depression (range: 0-27; higher scores = worse outcome)

9. Scale for Suicide Ideation [infusion +24 hours (1 day)]

   suicidal ideation/thoughts; range 0-38; high score=worse outcome

10. Scale for Suicide Ideation [infusion +5 days (4 days)]

    suicidal ideation/thoughts; range 0-38; high score=worse outcome

11. Scale for Suicide Ideation [infusion +12 days (7 days)]

    suicidal ideation/thoughts; range 0-38; high score=worse outcome

12. Scale for Suicide Ideation [infusion +1 month (1 week)]

    suicidal ideation/thoughts; range 0-38; high score=worse outcome

13. Scale for Suicide Ideation [infusion +3 months (1 week)]

    suicidal ideation/thoughts; range 0-38; high score=worse outcome

14. Scale for Suicide Ideation [infusion +6 months (1 week)]

    suicidal ideation/thoughts; range 0-38; high score=worse outcome

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• Rebecca Price

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rebecca Price, Assistant Professor of Psychiatry and Psychology, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT04154150
• Other Study ID Numbers: STUDY19100041
• First Posted: Nov 6, 2019
• Last Update Posted: Apr 7, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Suicide; Suicide, Attempted; Ketamine

Study Results

No Results Posted as of Apr 7, 2022