Trial · NCT04592809
Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents
NCT04592809, Phase 3, Completed, University of Texas Southwestern Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents. Trials, record NCT04592809. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04592809
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents
- NCT number
- NCT04592809
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 50 participants, actual
- Lead sponsor
- University of Texas Southwestern Medical Center
- Conditions
- Suicide, Attempted, Suicide and Depression, Suicide Threat
- Interventions
- Ketamine Hydrochloride, Midazolam Hydrochloride
- First posted
- 2020-10-19
- Last updated
- 2026-10-15
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Days to First Suicidal Event | 12 weeks | The primary outcome is number of days from the beginning of the study until the first suicidal event. A suicidal event is defined as a suicide attempt, or emergency department visit or inpatient hospitalization due to suicidality. Concise Health Risk Tracking Clinician-Rated Behavior Module (CHRT-C) will be used to identify suicidal events. The CHRT-C consists of nine clinician-rated yes/no items about specific behaviors (i.e., suicidal ideation, suicidal attempt, preparatory acts, non-suicidal self-injury (NSSI), other injuries, etc.). At the initial administration, this instrument captures lifetime information; at subsequent administrations, it will capture information since the last visit. Mean (Standard Error) days to event was estimated by Kaplan-Meier survival curves. |
| Primary | Number of Days to First Suicidal Event (by Sex) | 12 weeks | The primary outcome is number of days from the beginning of the study until the first suicidal event. A suicidal event is defined as a suicide attempt, or emergency department visit or inpatient hospitalization due to suicidality. Concise Health Risk Tracking Clinician-Rated Behavior Module (CHRT-C) will be used to identify suicidal events. The CHRT-C consists of nine clinician-rated yes/no items about specific behaviors (i.e., suicidal ideation, suicidal attempt, preparatory acts, non-suicidal self-injury (NSSI), other injuries, etc.). At the initial administration, this instrument captures lifetime information; at subsequent administrations, it will capture information since the last visit. Mean (Standard Error) days to event was estimated by Kaplan-Meier survival curves. |
| Primary | Number of Days to First Suicidal Event (by Ethnicity) | 12 weeks | The primary outcome is number of days from the beginning of the study until the first suicidal event. A suicidal event is defined as a suicide attempt, or emergency department visit or inpatient hospitalization due to suicidality. Concise Health Risk Tracking Clinician-Rated Behavior Module (CHRT-C) will be used to identify suicidal events. The CHRT-C consists of nine clinician-rated yes/no items about specific behaviors (i.e., suicidal ideation, suicidal attempt, preparatory acts, non-suicidal self-injury (NSSI), other injuries, etc.). At the initial administration, this instrument captures lifetime information; at subsequent administrations, it will capture information since the last visit. Mean (Standard Error) days to event was estimated by Kaplan-Meier survival curves. |
| Primary | Number of Days to First Suicidal Event (by Race) | 12 weeks | The primary outcome is number of days from the beginning of the study until the first suicidal event. A suicidal event is defined as a suicide attempt, or emergency department visit or inpatient hospitalization due to suicidality. Concise Health Risk Tracking Clinician-Rated Behavior Module (CHRT-C) will be used to identify suicidal events. The CHRT-C consists of nine clinician-rated yes/no items about specific behaviors (i.e., suicidal ideation, suicidal attempt, preparatory acts, non-suicidal self-injury (NSSI), other injuries, etc.). At the initial administration, this instrument captures lifetime information; at subsequent administrations, it will capture information since the last visit. Mean (Standard Error) days to event was estimated by Kaplan-Meier survival curves. |
| Secondary | Death/Suicide Implicit Association Test (IAT) Score | 2 weeks | The Death/Suicide Implicit Association Test (IAT) is computerized reaction-time test designed to measure implicit associations between the self and death. Participants categorize stimuli representing 1) self versus non-self, and 2) death versus life concepts. Based on response latencies across task conditions, a score is computed. Positive scores represent faster response time on association between death and self, while negative scores represent stronger associations between life and self. Thus, higher scores indicate a worse outcome. The scale is based on reaction times so there is not a fixed range. |
| Secondary | Concise Health Risk Tracking Self-Report (CHRT-SR) Score | 2 weeks | Concise Health Risk Tracking Self-Report (CHRT-SR) consists of 14 questions with responses ranging from 0 (strongly disagree) to 4 (strongly agree). A total score is calculated by the sum of all 14 responses, with a total ranging from 0 to 56. A higher score indicates a greater risk for suicide. |
| Secondary | Percentage of Participants With Suicidal Events/Behaviors as Measured by CHRT-C a Self Report Measure | 2 week | Concise Health Risk Tracking Clinician-Rated Behavior Module (CHRT-C). consists of nine clinician-rated yes/no items about specific behaviors (i.e., suicidal ideation, suicidal attempt, preparatory acts, non-suicidal self-injury (NSSI), other injuries, etc.). At the initial administration, this instrument captures lifetime information; at subsequent administrations, it will capture information since the last visit. a yes on any of the 9 questions indicates presence of suicidal event/behaviors (ideation, attempt, preparatory acts, non suicidal self injury, other injury). |
| Secondary | Inventory of Depressive Symptomatology (IDS) Self Report Score | 2 weeks | The Inventory of Depressive Symptomatology (IDS) Self Report is a depressive symptom severity measure that rates all nine criterion symptoms of MDD. The self-report (IDS-SR) consists of 30 questions with a total score of 0 to 84. A higher score indicates a higher level of depressive symptom severity. The self report (IDS-SR) will be completed at each visit. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42849709 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01MH125181 | Double-Blind Randomized Controlled Trial of Acute-Course of Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents | TRIVEDI, MADHUKAR H. | UT SOUTHWESTERN MEDICAL CENTER | NATIONAL INSTITUTE OF MENTAL HEALTH | 2020 to 2023 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Implicit Association Test (IAT) | Secondary outcome |
Source ConductCognition
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/NCT04592809
GET https://conductscience.org/api/trials/v1/NCT04592809/registered