Suicide, Attempted
Conditions
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.
Detailed 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.
Interventions
Single subanesthetic infusion of ketamine (0.5mg/kg)
BEHAVIORALCognitive training
8 sessions of computer-based cognitive training
BEHAVIORALSham Training
8 sessions of computer-based sham training
Sponsors
Rebecca Price
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery Asberg Depression Rating Scale | infusion +24 hours | depression severity; range 0-60; high score=worse outcome |
| Adult Suicide Ideation Questionnaire (Past Day Version) | infusion +24 hours | suicidal ideation/thoughts; range 0-150; high score=worse outcome |
| Adult Suicide Ideation Questionnaire | infusion +1 month | suicidal ideation/thoughts; range 0-150; high score=worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Occurrence of Suicidal Behaviors Per Medical Chart Review | infusion +6 months | Number of participants with occurrence of any suicidal act (derived from medical chart) including: re-attempt, re-hospitalization for suicidality, or completed suicide |
| Scale for Suicide Ideation | infusion +24 hours | suicidal ideation/thoughts; range 0-38; high score=worse outcome |
| Number of Participants Reporting Suicidal Behaviors Per the Columbia Suicide Severity Rating Scale (CSSRS) | infusion +6 months | 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. |
| Quick Inventory of Depressive Symptoms | infusion +24 hours | Self-reported depression (range: 0-27; higher scores = worse outcome) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketamine + Cognitive Training Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)
Cognitive training: 8 sessions of computer-based cognitive training | 7 |
| Ketamine + Sham Training Intravenous ketamine: Single subanesthetic infusion of ketamine (0.5mg/kg)
Sham Training: 8 sessions of computer-based sham training | 9 |
| Total | 16 |
Baseline characteristics
| Characteristic | Total | Ketamine + Cognitive Training | Ketamine + Sham Training |
|---|---|---|---|
| Adult Suicide Ideation Questionnaire | 91.9 units on a scale STANDARD_DEVIATION 32.3 | 85.0 units on a scale STANDARD_DEVIATION 35.2 | 96.6 units on a scale STANDARD_DEVIATION 31.5 |
| Age, Continuous | 34.06 years STANDARD_DEVIATION 16.06 | 32.29 years STANDARD_DEVIATION 14.8 | 35.44 years STANDARD_DEVIATION 17.74 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 6 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Montgomery Asberg Depression Rating Scale | 37.8 units on a scale STANDARD_DEVIATION 6.2 | 39 units on a scale STANDARD_DEVIATION 6.4 | 36.8 units on a scale STANDARD_DEVIATION 6.3 |
| Quick Inventory of Depressive Symptoms | 15.9 units on a scale STANDARD_DEVIATION 5.1 | 17.8 units on a scale STANDARD_DEVIATION 3.1 | 14.4 units on a scale STANDARD_DEVIATION 5.95 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 5 Participants | 8 Participants |
| Scale for Suicide Ideation | 29.6 units on a scale STANDARD_DEVIATION 1.8 | 30.3 units on a scale STANDARD_DEVIATION 2.2 | 29.3 units on a scale STANDARD_DEVIATION 1.7 |
| Sex/Gender, Customized Female | 8 Participants | 5 Participants | 3 Participants |
| Sex/Gender, Customized Male | 7 Participants | 2 Participants | 5 Participants |
| Sex/Gender, Customized Transgender (female-to-male) | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 9 |
| other Total, other adverse events | 7 / 7 | 9 / 9 |
| serious Total, serious adverse events | 0 / 7 | 0 / 9 |
Outcome results
Primary
Adult Suicide Ideation Questionnaire
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Time frame: infusion +1 month
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Adult Suicide Ideation Questionnaire | 23.60 score on a scale | Standard Deviation 22.9 |
| Ketamine + Sham Training | Adult Suicide Ideation Questionnaire | 41.83 score on a scale | Standard Deviation 48 |
Primary
Adult Suicide Ideation Questionnaire
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Time frame: infusion +3 months
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Adult Suicide Ideation Questionnaire | 25.20 score on a scale | Standard Deviation 26.2 |
| Ketamine + Sham Training | Adult Suicide Ideation Questionnaire | 37.50 score on a scale | Standard Deviation 46.5 |
Primary
Adult Suicide Ideation Questionnaire
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Time frame: infusion +6 months
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Adult Suicide Ideation Questionnaire | 29.5 score on a scale | Standard Deviation 40.3 |
| Ketamine + Sham Training | Adult Suicide Ideation Questionnaire | 45.75 score on a scale | Standard Deviation 60.9 |
Primary
Adult Suicide Ideation Questionnaire (Past Day Version)
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Time frame: infusion +24 hours
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Adult Suicide Ideation Questionnaire (Past Day Version) | 32.67 score on a scale | Standard Deviation 8.45 |
| Ketamine + Sham Training | Adult Suicide Ideation Questionnaire (Past Day Version) | 41.89 score on a scale | Standard Deviation 38.6 |
Primary
Adult Suicide Ideation Questionnaire (Past Day Version)
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Time frame: infusion +5 days
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Adult Suicide Ideation Questionnaire (Past Day Version) | 20.00 score on a scale | Standard Deviation 9.98 |
| Ketamine + Sham Training | Adult Suicide Ideation Questionnaire (Past Day Version) | 22.88 score on a scale | Standard Deviation 10.7 |
Primary
Adult Suicide Ideation Questionnaire (Past Day Version)
suicidal ideation/thoughts; range 0-150; high score=worse outcome
Time frame: infusion +12 days
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Adult Suicide Ideation Questionnaire (Past Day Version) | 17.17 score on a scale | Standard Deviation 13.4 |
| Ketamine + Sham Training | Adult Suicide Ideation Questionnaire (Past Day Version) | 31.86 score on a scale | Standard Deviation 34.6 |
Primary
Montgomery Asberg Depression Rating Scale
depression severity; range 0-60; high score=worse outcome
Time frame: infusion +24 hours
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Montgomery Asberg Depression Rating Scale | 18.43 score on a scale | Standard Deviation 8.5 |
| Ketamine + Sham Training | Montgomery Asberg Depression Rating Scale | 15.44 score on a scale | Standard Deviation 10.9 |
Primary
Montgomery Asberg Depression Rating Scale
depression severity; range 0-60; high score=worse outcome
Time frame: infusion +3 months
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Montgomery Asberg Depression Rating Scale | 13.00 score on a scale | Standard Deviation 13.6 |
| Ketamine + Sham Training | Montgomery Asberg Depression Rating Scale | 14.71 score on a scale | Standard Deviation 10.2 |
Primary
Montgomery Asberg Depression Rating Scale
depression severity; range 0-60; high score=worse outcome
Time frame: infusion +6 months
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Montgomery Asberg Depression Rating Scale | 13.20 score on a scale | Standard Deviation 14.7 |
| Ketamine + Sham Training | Montgomery Asberg Depression Rating Scale | 17.43 score on a scale | Standard Deviation 9.9 |
Primary
Montgomery Asberg Depression Rating Scale
depression severity; range 0-60; high score=worse outcome
Time frame: infusion +1 month
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Montgomery Asberg Depression Rating Scale | 20.67 score on a scale | Standard Deviation 7.6 |
| Ketamine + Sham Training | Montgomery Asberg Depression Rating Scale | 14.00 score on a scale | Standard Deviation 13.4 |
Primary
Montgomery Asberg Depression Rating Scale
depression severity; range 0-60; high score=worse outcome
Time frame: infusion +12 days
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Montgomery Asberg Depression Rating Scale | 13.67 score on a scale | Standard Deviation 14.2 |
| Ketamine + Sham Training | Montgomery Asberg Depression Rating Scale | 17.29 score on a scale | Standard Deviation 11.9 |
Primary
Montgomery Asberg Depression Rating Scale
depression severity; range 0-60; high score=worse outcome
Time frame: infusion +5 days
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Montgomery Asberg Depression Rating Scale | 19.14 score on a scale | Standard Deviation 9.8 |
| Ketamine + Sham Training | Montgomery Asberg Depression Rating Scale | 16.13 score on a scale | Standard Deviation 9.2 |
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.
Time frame: infusion +6 months
Population: All participants who were assigned to the arm and were willing and able to complete at least one CSSRS interview at any point during follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ketamine + Cognitive Training | Number of Participants Reporting Suicidal Behaviors Per the Columbia Suicide Severity Rating Scale (CSSRS) | 1 Participants |
| Ketamine + Sham Training | Number of Participants Reporting Suicidal Behaviors Per the Columbia Suicide Severity Rating Scale (CSSRS) | 1 Participants |
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
Time frame: infusion +6 months
Population: All participants who were assigned to the arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ketamine + Cognitive Training | Number of Participants With Occurrence of Suicidal Behaviors Per Medical Chart Review | 3 Participants |
| Ketamine + Sham Training | Number of Participants With Occurrence of Suicidal Behaviors Per Medical Chart Review | 4 Participants |
Secondary
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time frame: infusion +24 hours
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Quick Inventory of Depressive Symptoms | 12.83 score on a scale | Standard Deviation 4.1 |
| Ketamine + Sham Training | Quick Inventory of Depressive Symptoms | 11.22 score on a scale | Standard Deviation 6 |
Secondary
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time frame: infusion +5 days
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Quick Inventory of Depressive Symptoms | 9.86 score on a scale | Standard Deviation 5.8 |
| Ketamine + Sham Training | Quick Inventory of Depressive Symptoms | 9.50 score on a scale | Standard Deviation 6.9 |
Secondary
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time frame: infusion +12 days
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Quick Inventory of Depressive Symptoms | 8.33 score on a scale | Standard Deviation 7.1 |
| Ketamine + Sham Training | Quick Inventory of Depressive Symptoms | 9.86 score on a scale | Standard Deviation 7.3 |
Secondary
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time frame: infusion +1 month
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Quick Inventory of Depressive Symptoms | 9.60 score on a scale | Standard Deviation 3.4 |
| Ketamine + Sham Training | Quick Inventory of Depressive Symptoms | 9.33 score on a scale | Standard Deviation 7 |
Secondary
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time frame: infusion +3 months
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Quick Inventory of Depressive Symptoms | 10.60 score on a scale | Standard Deviation 7.1 |
| Ketamine + Sham Training | Quick Inventory of Depressive Symptoms | 9.17 score on a scale | Standard Deviation 7.5 |
Secondary
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Time frame: infusion +6 months
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Quick Inventory of Depressive Symptoms | 10.00 score on a scale | Standard Deviation 10 |
| Ketamine + Sham Training | Quick Inventory of Depressive Symptoms | 12.25 score on a scale | Standard Deviation 10.6 |
Secondary
Scale for Suicide Ideation
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Time frame: infusion +24 hours
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure. Measure added to protocol after first 4 patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Scale for Suicide Ideation | 8.50 score on a scale | Standard Deviation 12 |
| Ketamine + Sham Training | Scale for Suicide Ideation | 0.80 score on a scale | Standard Deviation 1.3 |
Secondary
Scale for Suicide Ideation
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Time frame: infusion +5 days
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure. Measure added to protocol after first 4 patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Scale for Suicide Ideation | 0.50 score on a scale | Standard Deviation 0.71 |
| Ketamine + Sham Training | Scale for Suicide Ideation | 6.60 score on a scale | Standard Deviation 9.4 |
Secondary
Scale for Suicide Ideation
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Time frame: infusion +12 days
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure. Measure added to protocol after first 4 patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Sham Training | Scale for Suicide Ideation | 4.50 score on a scale | Standard Deviation 9 |
Secondary
Scale for Suicide Ideation
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Time frame: infusion +1 month
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure. Measure added to protocol after first 4 patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Scale for Suicide Ideation | 13.00 score on a scale | — |
| Ketamine + Sham Training | Scale for Suicide Ideation | 4.67 score on a scale | Standard Deviation 7.2 |
Secondary
Scale for Suicide Ideation
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Time frame: infusion +3 months
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure. Measure added to protocol after first 4 patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Scale for Suicide Ideation | 4.00 score on a scale | Standard Deviation 7.3 |
| Ketamine + Sham Training | Scale for Suicide Ideation | 5.83 score on a scale | Standard Deviation 9.2 |
Secondary
Scale for Suicide Ideation
suicidal ideation/thoughts; range 0-38; high score=worse outcome
Time frame: infusion +6 months
Population: All participants who were assigned to the arm and were willing and able to complete this specific measure. Measure added to protocol after first 4 patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketamine + Cognitive Training | Scale for Suicide Ideation | 5.40 score on a scale | Standard Deviation 12.1 |
| Ketamine + Sham Training | Scale for Suicide Ideation | 6.86 score on a scale | Standard Deviation 9.2 |