Trial · NCT04260607
Initiating Ketamine in Acutely Suicidal Patients in the Emergency Department
NCT04260607, Phase 3, Terminated, Naval Medical Center Camp Lejeune; results first posted 2024-11-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Initiating Ketamine in Acutely Suicidal Patients in the Emergency Department. Trials, record NCT04260607. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04260607
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Initiating Ketamine in Acutely Suicidal Patients in the Emergency Department
- NCT number
- NCT04260607
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1 participants, actual
- Lead sponsor
- Naval Medical Center Camp Lejeune
- Conditions
- Suicide, Suicide Threat, Depression Severe
- Interventions
- Ketamine Hydrochloride, Normal saline
- First posted
- 2020-02-07
- Last updated
- 2025-05-14
- Results first posted
- 2024-11-19
- Limitations and caveats
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 one patient had been assigned to the experimental group, and 0 patients to the placebo group. While data from the one patient was reported in the results with descriptive statistics, no inferential analysis could be performed.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Suicidal Severity - Clinical Efficacy | 4 hour+/1 after infusion completion (performed for placebo and drug arms) | 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. |
| Primary | Suicidal Severity - Clinical Efficacy | 24-36 hours after infusion completion (performed for placebo and drug arms) | 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. |
| Primary | Suicidal Severity - Efficacy at 1 Week | 1week+/-1 day after infusion completion (performed for placebo and drug arms) | 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. |
| Primary | Depression Symptoms - Clinical Efficacy | 4 hours +/-1 after infusion completion (Performed for placebo and drug arms) | 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. |
| Primary | Depression Symptoms - Clinical Efficacy | 24-46 hours after infusion completion (Performed for placebo and drug arms) | 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. |
| Primary | Depression Symptoms - Efficacy at 1 Week | 1 week +/-1 day after infusion completion, performed for placebo and drug arms | 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. |
| Secondary | Length of Hospital Stay | Performed on medical record review at 1 week | Difference in time between date of hospital admission to transfer or hospital discharge. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Suicidal Severity - Clinical Efficacy | 4 hour+/1 after infusion completion (performed for placebo and drug arms) | 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. | Units on a Scale | MEDIAN |
| PRIMARY | Suicidal Severity - Clinical Efficacy | 24-36 hours after infusion completion (performed for placebo and drug arms) | 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. | Units on a Scale | MEDIAN |
| PRIMARY | Suicidal Severity - Efficacy at 1 Week | 1week+/-1 day after infusion completion (performed for placebo and drug arms) | 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. | Units on a Scale | MEDIAN |
| PRIMARY | Depression Symptoms - Clinical Efficacy | 4 hours +/-1 after infusion completion (Performed for placebo and drug arms) | 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. | units on a scale | MEDIAN |
| PRIMARY | Depression Symptoms - Clinical Efficacy | 24-46 hours after infusion completion (Performed for placebo and drug arms) | 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. | units on a scale | MEDIAN |
| PRIMARY | Depression Symptoms - Efficacy at 1 Week | 1 week +/-1 day after infusion completion, performed for placebo and drug arms | 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. | units on a scale | MEDIAN |
| SECONDARY | Length of Hospital Stay | Performed on medical record review at 1 week | The length of hospital stay was not recorded for the patient. |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Suicidal Severity - Clinical Efficacy | Experimental-Ketamine | 3 | Full Range 3 to 3 | Units on a Scale | |
| Suicidal Severity - Clinical Efficacy | Experimental-Ketamine | 2 | Full Range 2 to 2 | Units on a Scale | |
| Suicidal Severity - Efficacy at 1 Week | Experimental-Ketamine | 6 | Full Range 6 to 6 | Units on a Scale | |
| Depression Symptoms - Clinical Efficacy | Experimental-Ketamine | 7 | Full Range 7 to 7 | units on a scale | |
| Depression Symptoms - Clinical Efficacy | Experimental-Ketamine | 2 | Full Range 2 to 2 | units on a scale | |
| Depression Symptoms - Efficacy at 1 Week | Experimental-Ketamine | 9.5 | Full Range 9.5 to 9.5 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Experimental-Ketamine | 1 | |
| Overall Study | STARTED | Placebo-Saline | 0 | |
| Overall Study | COMPLETED | Experimental-Ketamine | 1 | |
| Overall Study | COMPLETED | Placebo-Saline | 0 | |
| Overall Study | NOT COMPLETED | Experimental-Ketamine | 0 | |
| Overall Study | NOT COMPLETED | Placebo-Saline | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Mild Severity AE | Psychiatric disorders | Experimental-Ketamine | 1 | 1 | 1 |
| other | Mild Severity AE | Psychiatric disorders | Placebo-Saline | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental-Ketamine | 0 | 1 |
| Total, all-cause mortality | Placebo-Saline | 0 | 0 |
| Total, other adverse events | Experimental-Ketamine | 1 | 1 |
| Total, other adverse events | Placebo-Saline | 0 | 0 |
| Total, serious adverse events | Experimental-Ketamine | 0 | 1 |
| Total, serious adverse events | Placebo-Saline | 0 | 0 |
Source ClinicalTrials.gov
Papers45
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04260607
GET https://conductscience.org/api/trials/v1/NCT04260607/papers?page=2