Trial Outcomes & Findings for Initiating Ketamine in Acutely Suicidal Patients in the Emergency Department (NCT NCT04260607)
NCT ID: NCT04260607
Last Updated: 2025-05-14
Results Overview
Suicidal severity is measured by the total score on the Beck Scale for Suicide Ideation (BSS or BSSI). The BSS is a 21-item scale, where each item contains a group of statements that are rated from 0 to 2. Items 1 to 5 comprise a screening subscale. If the patient scores 0 in total on items 4 and 5, items 6 to 19 are skipped. Item 21 is only asked if the patient has attempted suicide at least once. The screening subscale can range from 0 to 10 points, whereas the total score can range from 0 to 42 points. A high total score corresponds with an increased number of specific suicidal characteristics that require greater clinical scrutiny.
TERMINATED
PHASE3
1 participants
4 hour+/1 after infusion completion (performed for placebo and drug arms)
2025-05-14
Participant Flow
Subjects recruitment occurred from main ED from 2019-2021
Medical Record review completed
Participant milestones
| Measure |
Experimental-Ketamine
single dose IV Ketamine (Ketalar) 0.5mg/kg in 100ml Normal Saline infused over 40 minutes
Ketamine Hydrochloride: Experimental Procedure
1. Baseline evaluation of suicidal severity (BSSI) \& degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires.
2. The experimental and placebo arms will receive a single dose of IV ketamine, 0.5 mg/kg in 100 cc NS or 100 cc of NS infused over 40 minutes.
3. Post ketamine re-evaluation of outcome measures at four and twenty-four hours will determine clinical effectiveness of ketamine intervention
4. Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention.
5. Post ketamine re-evaluation of outcome measure at one-week post infusion will elucidate ketamine's durability of effect.
|
Placebo-Saline
100ml Normal Saline infused over 40 minutes
Normal saline: Experimental Procedure
1. Baseline evaluation of suicidal severity (BSSI) \& degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires.
2. The placebo arms will receive a single dose of 100 cc of NS infused over 40 minutes.
3. Post Placebo infusion re-evaluation of outcome measures at four and twenty-four hours
4. Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention.
5. Post Normal Saline re-evaluation of outcome measure at one-week post infusion.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental-Ketamine
n=1 Participants
single dose IV Ketamine (Ketalar) 0.5mg/kg in 100ml Normal Saline infused over 40 minutes
Ketamine Hydrochloride: Experimental Procedure
1. Baseline evaluation of suicidal severity (BSSI) \& degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires.
2. The experimental and placebo arms will receive a single dose of IV ketamine, 0.5 mg/kg in 100 cc NS or 100 cc of NS infused over 40 minutes.
3. Post ketamine re-evaluation of outcome measures at four and twenty-four hours will determine clinical effectiveness of ketamine intervention
4. Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention.
5. Post ketamine re-evaluation of outcome measure at one-week post infusion will elucidate ketamine's durability of effect.
|
Placebo-Saline
100ml Normal Saline infused over 40 minutes
Normal saline: Experimental Procedure
1. Baseline evaluation of suicidal severity (BSSI) \& degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires.
2. The placebo arms will receive a single dose of 100 cc of NS infused over 40 minutes.
3. Post Placebo infusion re-evaluation of outcome measures at four and twenty-four hours
4. Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention.
5. Post Normal Saline re-evaluation of outcome measure at one-week post infusion.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=1 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=1 Participants
|
—
|
1 Participants
n=1 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=1 Participants
|
|
Age, Continuous
|
23 Years
n=1 Participants
|
—
|
23 Years
n=1 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=1 Participants
|
—
|
1 Participants
n=1 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Beck Scale for Suicide Ideation (BSS)
Screening Subscore
|
7 units on a scale
n=1 Participants
|
—
|
7 units on a scale
n=1 Participants
|
|
Beck Scale for Suicide Ideation (BSS)
Total Score
|
29 units on a scale
n=1 Participants
|
—
|
29 units on a scale
n=1 Participants
|
|
Montgomery Asberg Depression Rating Scale (MADRS)
|
20 units on a scale
n=1 Participants
|
—
|
20 units on a scale
n=1 Participants
|
PRIMARY outcome
Timeframe: 4 hour+/1 after infusion completion (performed for placebo and drug arms)Population: As a busy MTF we were unable to retain a health care provider with the appropriate expertise to buy-in to this study once the initiating PI left military service. At the time the PI left military service, only 1 patient had been assigned to the experimental group, and 0 patients to the placebo group.
Suicidal severity is measured by the total score on the Beck Scale for Suicide Ideation (BSS or BSSI). The BSS is a 21-item scale, where each item contains a group of statements that are rated from 0 to 2. Items 1 to 5 comprise a screening subscale. If the patient scores 0 in total on items 4 and 5, items 6 to 19 are skipped. Item 21 is only asked if the patient has attempted suicide at least once. The screening subscale can range from 0 to 10 points, whereas the total score can range from 0 to 42 points. A high total score corresponds with an increased number of specific suicidal characteristics that require greater clinical scrutiny.
Outcome measures
| Measure |
Experimental-Ketamine
n=1 Participants
single dose IV Ketamine (Ketalar) 0.5mg/kg in 100ml Normal Saline infused over 40 minutes
Ketamine Hydrochloride: Experimental Procedure
1. Baseline evaluation of suicidal severity (BSSI) \& degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires.
2. The experimental and placebo arms will receive a single dose of IV ketamine, 0.5 mg/kg in 100 cc NS or 100 cc of NS infused over 40 minutes.
3. Post ketamine re-evaluation of outcome measures at four and twenty-four hours will determine clinical effectiveness of ketamine intervention
4. Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention.
5. Post ketamine re-evaluation of outcome measure at one-week post infusion will elucidate ketamine's durability of effect.
|
Placebo-Saline
100ml Normal Saline infused over 40 minutes
Normal saline: Experimental Procedure
1. Baseline evaluation of suicidal severity (BSSI) \& degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires.
2. The placebo arms will receive a single dose of 100 cc of NS infused over 40 minutes.
3. Post Placebo infusion re-evaluation of outcome measures at four and twenty-four hours
4. Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention.
5. Post Normal Saline re-evaluation of outcome measure at one-week post infusion.
|
|---|---|---|
|
Suicidal Severity - Clinical Efficacy
|
3 Units on a Scale
Interval 3.0 to 3.0
|
—
|
PRIMARY outcome
Timeframe: 24-36 hours after infusion completion (performed for placebo and drug arms)Population: As a busy MTF we were unable to retain a health care provider with the appropriate expertise to buy-in to this study once the initiating PI left military service. At the time the PI left military service, only 1 patient had been assigned to the experimental group, and 0 patients to the placebo group.
Suicidal severity is measured by the total score on the Beck Scale for Suicide Ideation (BSS or BSSI). The BSS is a 21-item scale, where each item contains a group of statements that are rated from 0 to 2. Items 1 to 5 comprise a screening subscale. If the patient scores 0 in total on items 4 and 5, items 6 to 19 are skipped. Item 21 is only asked if the patient has attempted suicide at least once. The screening subscale can range from 0 to 10 points, whereas the total score can range from 0 to 42 points. A high total score corresponds with an increased number of specific suicidal characteristics that require greater clinical scrutiny.
Outcome measures
| Measure |
Experimental-Ketamine
n=1 Participants
single dose IV Ketamine (Ketalar) 0.5mg/kg in 100ml Normal Saline infused over 40 minutes
Ketamine Hydrochloride: Experimental Procedure
1. Baseline evaluation of suicidal severity (BSSI) \& degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires.
2. The experimental and placebo arms will receive a single dose of IV ketamine, 0.5 mg/kg in 100 cc NS or 100 cc of NS infused over 40 minutes.
3. Post ketamine re-evaluation of outcome measures at four and twenty-four hours will determine clinical effectiveness of ketamine intervention
4. Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention.
5. Post ketamine re-evaluation of outcome measure at one-week post infusion will elucidate ketamine's durability of effect.
|
Placebo-Saline
100ml Normal Saline infused over 40 minutes
Normal saline: Experimental Procedure
1. Baseline evaluation of suicidal severity (BSSI) \& degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires.
2. The placebo arms will receive a single dose of 100 cc of NS infused over 40 minutes.
3. Post Placebo infusion re-evaluation of outcome measures at four and twenty-four hours
4. Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention.
5. Post Normal Saline re-evaluation of outcome measure at one-week post infusion.
|
|---|---|---|
|
Suicidal Severity - Clinical Efficacy
|
2 Units on a Scale
Interval 2.0 to 2.0
|
—
|
PRIMARY outcome
Timeframe: 1week+/-1 day after infusion completion (performed for placebo and drug arms)Population: As a busy MTF we were unable to retain a health care provider with the appropriate expertise to buy-in to this study once the initiating PI left military service. At the time the PI left military service, only 1 patient had been assigned to the experimental group, and 0 patients to the placebo group.
Suicidal severity is measured by the total score on the Beck Scale for Suicide Ideation (BSS or BSSI). The BSS is a 21-item scale, where each item contains a group of statements that are rated from 0 to 2. Items 1 to 5 comprise a screening subscale. If the patient scores 0 in total on items 4 and 5, items 6 to 19 are skipped. Item 21 is only asked if the patient has attempted suicide at least once. The screening subscale can range from 0 to 10 points, whereas the total score can range from 0 to 42 points. A high total score corresponds with an increased number of specific suicidal characteristics that require greater clinical scrutiny.
Outcome measures
| Measure |
Experimental-Ketamine
n=1 Participants
single dose IV Ketamine (Ketalar) 0.5mg/kg in 100ml Normal Saline infused over 40 minutes
Ketamine Hydrochloride: Experimental Procedure
1. Baseline evaluation of suicidal severity (BSSI) \& degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires.
2. The experimental and placebo arms will receive a single dose of IV ketamine, 0.5 mg/kg in 100 cc NS or 100 cc of NS infused over 40 minutes.
3. Post ketamine re-evaluation of outcome measures at four and twenty-four hours will determine clinical effectiveness of ketamine intervention
4. Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention.
5. Post ketamine re-evaluation of outcome measure at one-week post infusion will elucidate ketamine's durability of effect.
|
Placebo-Saline
100ml Normal Saline infused over 40 minutes
Normal saline: Experimental Procedure
1. Baseline evaluation of suicidal severity (BSSI) \& degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires.
2. The placebo arms will receive a single dose of 100 cc of NS infused over 40 minutes.
3. Post Placebo infusion re-evaluation of outcome measures at four and twenty-four hours
4. Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention.
5. Post Normal Saline re-evaluation of outcome measure at one-week post infusion.
|
|---|---|---|
|
Suicidal Severity - Efficacy at 1 Week
|
6 Units on a Scale
Interval 6.0 to 6.0
|
—
|
PRIMARY outcome
Timeframe: 4 hours +/-1 after infusion completion (Performed for placebo and drug arms)Population: As a busy MTF we were unable to retain a health care provider with the appropriate expertise to buy-in to this study once the initiating PI left military service. At the time the PI left military service, only 1 patient had been assigned to the experimental group, and 0 patients to the placebo group.
Depression symptoms are measured by the total score on the Montgomery Asberg Depression Rating Scale (MADRS). The MADRS scale consists of 9 items. Each item is scored between 0 and 3, in intervals of 0.5 The total scores range between 0 and 27, with higher scores indicating more severe depressive symptoms.
Outcome measures
| Measure |
Experimental-Ketamine
n=1 Participants
single dose IV Ketamine (Ketalar) 0.5mg/kg in 100ml Normal Saline infused over 40 minutes
Ketamine Hydrochloride: Experimental Procedure
1. Baseline evaluation of suicidal severity (BSSI) \& degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires.
2. The experimental and placebo arms will receive a single dose of IV ketamine, 0.5 mg/kg in 100 cc NS or 100 cc of NS infused over 40 minutes.
3. Post ketamine re-evaluation of outcome measures at four and twenty-four hours will determine clinical effectiveness of ketamine intervention
4. Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention.
5. Post ketamine re-evaluation of outcome measure at one-week post infusion will elucidate ketamine's durability of effect.
|
Placebo-Saline
100ml Normal Saline infused over 40 minutes
Normal saline: Experimental Procedure
1. Baseline evaluation of suicidal severity (BSSI) \& degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires.
2. The placebo arms will receive a single dose of 100 cc of NS infused over 40 minutes.
3. Post Placebo infusion re-evaluation of outcome measures at four and twenty-four hours
4. Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention.
5. Post Normal Saline re-evaluation of outcome measure at one-week post infusion.
|
|---|---|---|
|
Depression Symptoms - Clinical Efficacy
|
7 units on a scale
Interval 7.0 to 7.0
|
—
|
PRIMARY outcome
Timeframe: 24-46 hours after infusion completion (Performed for placebo and drug arms)Population: As a busy MTF we were unable to retain a health care provider with the appropriate expertise to buy-in to this study once the initiating PI left military service. At the time the PI left military service, only 1 patient had been assigned to the experimental group, and 0 patients to the placebo group.
Depression symptoms are measured by the total score on the Montgomery Asberg Depression Rating Scale (MADRS). The MADRS scale consists of 9 items. Each item is scored between 0 and 3, in intervals of 0.5 The total scores range between 0 and 27, with higher scores indicating more severe depressive symptoms.
Outcome measures
| Measure |
Experimental-Ketamine
n=1 Participants
single dose IV Ketamine (Ketalar) 0.5mg/kg in 100ml Normal Saline infused over 40 minutes
Ketamine Hydrochloride: Experimental Procedure
1. Baseline evaluation of suicidal severity (BSSI) \& degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires.
2. The experimental and placebo arms will receive a single dose of IV ketamine, 0.5 mg/kg in 100 cc NS or 100 cc of NS infused over 40 minutes.
3. Post ketamine re-evaluation of outcome measures at four and twenty-four hours will determine clinical effectiveness of ketamine intervention
4. Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention.
5. Post ketamine re-evaluation of outcome measure at one-week post infusion will elucidate ketamine's durability of effect.
|
Placebo-Saline
100ml Normal Saline infused over 40 minutes
Normal saline: Experimental Procedure
1. Baseline evaluation of suicidal severity (BSSI) \& degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires.
2. The placebo arms will receive a single dose of 100 cc of NS infused over 40 minutes.
3. Post Placebo infusion re-evaluation of outcome measures at four and twenty-four hours
4. Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention.
5. Post Normal Saline re-evaluation of outcome measure at one-week post infusion.
|
|---|---|---|
|
Depression Symptoms - Clinical Efficacy
|
2 units on a scale
Interval 2.0 to 2.0
|
—
|
PRIMARY outcome
Timeframe: 1 week +/-1 day after infusion completion, performed for placebo and drug armsPopulation: As a busy MTF we were unable to retain a health care provider with the appropriate expertise to buy-in to this study once the initiating PI left military service. At the time the PI left military service, only 1 patient had been assigned to the experimental group, and 0 patients to the placebo group.
Depression symptoms are measured by the total score on the Montgomery Asberg Depression Rating Scale (MADRS). The MADRS scale consists of 9 items. Each item is scored between 0 and 3, in intervals of 0.5 The total scores range between 0 and 27, with higher scores indicating more severe depressive symptoms.
Outcome measures
| Measure |
Experimental-Ketamine
n=1 Participants
single dose IV Ketamine (Ketalar) 0.5mg/kg in 100ml Normal Saline infused over 40 minutes
Ketamine Hydrochloride: Experimental Procedure
1. Baseline evaluation of suicidal severity (BSSI) \& degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires.
2. The experimental and placebo arms will receive a single dose of IV ketamine, 0.5 mg/kg in 100 cc NS or 100 cc of NS infused over 40 minutes.
3. Post ketamine re-evaluation of outcome measures at four and twenty-four hours will determine clinical effectiveness of ketamine intervention
4. Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention.
5. Post ketamine re-evaluation of outcome measure at one-week post infusion will elucidate ketamine's durability of effect.
|
Placebo-Saline
100ml Normal Saline infused over 40 minutes
Normal saline: Experimental Procedure
1. Baseline evaluation of suicidal severity (BSSI) \& degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires.
2. The placebo arms will receive a single dose of 100 cc of NS infused over 40 minutes.
3. Post Placebo infusion re-evaluation of outcome measures at four and twenty-four hours
4. Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention.
5. Post Normal Saline re-evaluation of outcome measure at one-week post infusion.
|
|---|---|---|
|
Depression Symptoms - Efficacy at 1 Week
|
9.5 units on a scale
Interval 9.5 to 9.5
|
—
|
SECONDARY outcome
Timeframe: Performed on medical record review at 1 weekPopulation: The length of hospital stay was not recorded for the patient.
Difference in time between date of hospital admission to transfer or hospital discharge.
Outcome measures
Outcome data not reported
Adverse Events
Experimental-Ketamine
Placebo-Saline
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental-Ketamine
n=1 participants at risk
single dose IV Ketamine (Ketalar) 0.5mg/kg in 100ml Normal Saline infused over 40 minutes
Ketamine Hydrochloride: Experimental Procedure
1. Baseline evaluation of suicidal severity (BSSI) \& degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires.
2. The experimental and placebo arms will receive a single dose of IV ketamine, 0.5 mg/kg in 100 cc NS or 100 cc of NS infused over 40 minutes.
3. Post ketamine re-evaluation of outcome measures at four and twenty-four hours will determine clinical effectiveness of ketamine intervention
4. Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention.
5. Post ketamine re-evaluation of outcome measure at one-week post infusion will elucidate ketamine's durability of effect.
|
Placebo-Saline
100ml Normal Saline infused over 40 minutes
Normal saline: Experimental Procedure
1. Baseline evaluation of suicidal severity (BSSI) \& degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires.
2. The placebo arms will receive a single dose of 100 cc of NS infused over 40 minutes.
3. Post Placebo infusion re-evaluation of outcome measures at four and twenty-four hours
4. Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention.
5. Post Normal Saline re-evaluation of outcome measure at one-week post infusion.
|
|---|---|---|
|
Psychiatric disorders
Mild Severity AE
|
100.0%
1/1 • Number of events 1 • 2 years
N/A; Definition of adverse event and/or serious adverse event, is the same as the clinicaltrials.gov definition.
|
—
0/0 • 2 years
N/A; Definition of adverse event and/or serious adverse event, is the same as the clinicaltrials.gov definition.
|
Additional Information
Naval Medical Center Camp Lejeune
Naval Medical Center Camp Lejeune
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place