Suicide, AttemptedPhase 3TASKNCT04592809
Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents
A Phase 3 study testing Ketamine Hydrochloride and Midazolam Hydrochloride in people with Suicide, Attempted and Suicide and Depression, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This project aims to examine the signal of efficacy of ketamine, a rapidly acting medication shown to decrease suicidality in adults in as short as hours or days, as opposed to weeks. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Suicide, Attempted, Suicide and Depression, Suicide Threat
- What is being tested?
- Ketamine Hydrochloride and Midazolam Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2022to 31 Aug 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Study participants must:
- Be adolescents (aged 13-18 years);
- Have had a recent suicidal event (suicide attempt or significant suicidal ideation with a plan or intent warranting emergency evaluation or inpatient hospitalization within the past 90 days);
- Receiving standard of care treatment that includes clinically indicated psychosocial and/or psychopharmacological treatment;
- Have a current primary diagnosis of a depressive disorder based on the MINI-KID (other psychiatric disorders are acceptable, but must not be primary);
- Participants must be able to complete assessments in English. However, the parent(s) or legal guardians of minors may either speak English or Spanish
- Use effective method of contraception during and for 90 days following the end of treatment for female and male participants. Recommended methods of birth control are namely, consistent use of an approved hormonal birth control (pill/patches, rings), an intrauterine device (IUD), contraceptive injection, double barrier methods, sexual abstinence, or sterilization;
Who cannot join
- Study participants must not:
- Have a psychotic disorder, such as lifetime schizophrenia, or a pervasive or intellectual developmental disorder requiring substantial or very substantial support;
- Have current mania, hypomania, mixed episode, or obsessive-compulsive disorder;
- Have a primary diagnosis other than a depressive disorder;
- Have moderate to severe alcohol or substance use disorder within the past six months (based on MINI-KID); If there is a positive urine drug screen at screening, the urine drug screen will be repeated at each infusion visit. Positive urine drug screen will be reviewed by study physician and infusion will proceed as long as no safety risk was identified;
- If female, be pregnant, lactating, or nursing; Women of childbearing potential must have a negative urine pregnancy test prior to all infusions;
Show all 11Show fewer
- Have unstable medical conditions (stable for less than 3 months) or with clinically significant laboratory values or an electrocardiogram (ECG) that would pose significant risk;
- Be at serious suicidal risk that cannot be managed in the outpatient setting;
- Have prior treatment for depression with or contraindications to ketamine, esketamine, or, midazolam;
- Treatment with medications that may alter pharmacokinetics of ketamine, including moderate-to-strong inhibitors or inducers of CYP3A4 and CYP2B6, is exclusionary. Regarding pharmacodynamic interactions, medications that may increase heart rate or blood pressure such as the ADHD stimulant medications will be permitted with last dose at least 24 hours prior to infusion. All concomitant medications will be evaluated by the study physician to determine if the type and dose of concomitant medication requires discontinuation and will be excluded if the concomitant medication could substantially increase the risk of study infusion. A complete list of medications that are Not Allowed is available in Appendix D of the protocol. The study team will not ask the participant to discontinue any treatment (except for not taking ADHD medications for 24 hours before study treatment) just for the sake of taking part in this study;
- Weigh >120 kilograms at baseline. If participants are enrolled but exceed 120 kilograms at any time during the treatment period, they will be removed from the treatment portion of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-Blind Randomized Controlled Trial of Acute-Course of Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents
This project aims to examine the signal of efficacy of ketamine, a rapidly acting medication shown to decrease suicidality in adults in as short as hours or days, as opposed to weeks.
The study design is a double-blind, randomized, active-control trial of adolescents (ages 13-18 years) with recent suicidal behaviors (suicide attempt or increased suicidal ideation). All participants must be receiving standard of care treatment which may range broadly from both outpatient and inpatient programs which include clinically indicated psychosocial and/or psychopharmacological treatments. Ketamine/midazolam treatment will occur twice weekly during the first two weeks of the study, followed by weekly assessments through week 12.
Read the detailed description
Adolescent patients (ages 13-18) who have recent suicidality (defined as suicide attempt or urgent evaluation for a suicidal ideation or behavior), and who are receiving standard of care treatment (e.g., psychosocial and/or psychopharmacological treatment) will be recruited for participation in the study. Upon informed consent/assent, screening data will be collected regarding mood symptoms, suicidal ideation and behavior, associated comorbidities, and treatment history. Youth participants will be randomized to receive infusions of either ketamine or midazolam, which will be provided twice weekly for two weeks. Participants will then have follow-up assessments visits through week 12 to continue to monitoring outcome measures.
Participants may be recruited directly from their standard care outpatient provider, SPARC Intensive Outpatient Program (IOP) located at Children's Health Medical Center, from the Children's Health Emergency Department (ED) or inpatient psychiatric unit located at the Dallas campus. Participants may also be recruited into the study even if they are seen in the in emergency departments or inpatient hospitalization outside of University of Texas (UT) Southwestern and Children's Health Medical Center. Recruitment and consent procedures may begin during ED or inpatient hospitalization; however, as the study is an outpatient study, study procedures will not begin until the participant is discharged from the ED or inpatient hospital.
Recruitment efforts will target medically healthy male and female youths with recent suicide events who are either seeking care at an emergency room, admitted to an inpatient unit, enrolled in an IOP, or receiving adequate outpatient care with either psychopharmacological or psychosocial treatment following a suicide event.
Enrollment of 114 subjects is expected to take place over a period of approximately 36 months. Enrolled participants will be involved in the study for approximately 14 weeks. Visits include a Screening Visit, 4 Study Intervention Visits, and 11 Follow-Up Visits (combination of in-person and remote visits). Multiple streams of outcome measures will be utilized for this protocol, including self-report measures, research assessor-completed measures, clinic level measures, and behavioral measures.
Aim 1. Evaluate reduction in repeat suicidal events with ketamine.
Aim 2. Evaluate reduction in implicit suicidal cognition with ketamine.
Aim 3. Evaluate reduction in depressive symptoms and suicidality with ketamine.
- Conditions
- Suicide, Attempted, Suicide and Depression, Suicide Threat
- Being tested
- Ketamine Hydrochloride, Midazolam Hydrochloride
- Keywords
- depression, adolescent, suicidal ideation, suicide attempt, teen, child, intensive outpatient, inpatient hospitalization, depression treatment, suicide treatment
- Medical subject headings
- Suicide, Attempted, Suicide, Depression, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine HydrochlorideDrug
Also called Ketalar
infused over a 40 minute period
Midazolam HydrochlorideDrug
Also called Versed
infused over a 40 minute period
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Active comparator | 0.5 mg/kg intravenous ketamine will be administered 4 times in a 2 week period. Ketamine will be dissolved in 0.9% sodium chloride in a total volume of 100ml and administered with a syringe infusion pump at a constant rate. Receives: Drug: Ketamine Hydrochloride; Drug: Midazolam Hydrochloride |
| Midazolam | Active comparator | 0.02 mg/kg midazolam will be administered 4 times in a 2 week period. Midazolam will be dissolved in 0.9% sodium chloride in a total volume of 100ml and administered with a syringe infusion pump at a constant rate. Receives: Drug: Ketamine Hydrochloride; Drug: Midazolam Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days to First Suicidal Event
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.
Measured: 12 weeks
Number of Days to First Suicidal Event (by Sex)
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.
Measured: 12 weeks
Number of Days to First Suicidal Event (by Ethnicity)
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.
Measured: 12 weeks
Number of Days to First Suicidal Event (by Race)
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.
Measured: 12 weeks
Secondary outcomes (4)
Death/Suicide Implicit Association Test (IAT) Score
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.
Measured: 2 weeks
Concise Health Risk Tracking Self-Report (CHRT-SR) Score
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.
Measured: 2 weeks
Percentage of Participants With Suicidal Events/Behaviors as Measured by CHRT-C a Self Report Measure
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).
Measured: 2 week
Inventory of Depressive Symptomatology (IDS) Self Report Score
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start3 Oct 2022
- Primary completion1 Jul 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Youth will be randomized in 1:1 fashion to either intravenous ketamine (0.5 mg/kg) or midazolam (0.02 mg/kg) twice weekly for 2 weeks followed by weekly visits for 10 weeks (for a total of 12-week post-randomization observation period).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center
- Investigators
- Madhukar Trivedi, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592809
- Sponsor's protocol ID
- STU-2020-0973
- Other IDs
- R01MH125181
- Acronym
- TASK
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2020
- Last updated
- 15 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Trivedi MH, Chin Fatt CR, Ayvaci ER, Mayes TL, Jha MK, Pak TK, Rebstock S, Spain T, Walsh D, Kimatian S, Monastirsky M, Vasu S, Carmody TJ, Minhajuddin A, Kennard BD, Emslie GJ. Randomized controlled trial of acute ketamine versus midazolam for recurrence of suicidality in adolescents (TASK): Rationale, design, and baseline characteristics. Contemp Clin Trials. 2026 Oct 8;170:108498. doi: 10.1016/j.cct.2026.108498. Online ahead of print.
PubMed 42849709
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Randomized Controlled Trial of Acute-Course of Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents
- ClinicalTrials.gov ID
- NCT04592809
- Acronym / sponsor ID
- TASK / STU-2020-0973
- Conditions
- Suicide, Attempted, Suicide and Depression, Suicide Threat
- Keywords
- depression, adolescent, suicidal ideation, suicide attempt, teen, child, intensive outpatient, inpatient hospitalization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Posted 15 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to examine the signal of efficacy of ketamine, a rapidly acting medication shown to decrease suicidality in adults in as short as hours or days, as opposed to weeks.
The study design is a double-blind, randomized, active-control trial of adolescents (ages 13-18 years) with recent suicidal behaviors (suicide attempt or increased suicidal ideation). All participants must be receiving standard of care treatment which may range broadly from both outpatient and inpatient programs which include clinically indicated psychosocial and/or psychopharmacological treatments. Ketamine/midazolam treatment will occur twice weekly during the first two weeks of the study, followed by weekly assessments through week 12.
Detailed description
Adolescent patients (ages 13-18) who have recent suicidality (defined as suicide attempt or urgent evaluation for a suicidal ideation or behavior), and who are receiving standard of care treatment (e.g., psychosocial and/or psychopharmacological treatment) will be recruited for participation in the study. Upon informed consent/assent, screening data will be collected regarding mood symptoms, suicidal ideation and behavior, associated comorbidities, and treatment history. Youth participants will be randomized to receive infusions of either ketamine or midazolam, which will be provided twice weekly for two weeks. Participants will then have follow-up assessments visits through week 12 to continue to monitoring outcome measures.
Participants may be recruited directly from their standard care outpatient provider, SPARC Intensive Outpatient Program (IOP) located at Children's Health Medical Center, from the Children's Health Emergency Department (ED) or inpatient psychiatric unit located at the Dallas campus. Participants may also be recruited into the study even if they are seen in the in emergency departments or inpatient hospitalization outside of University of Texas (UT) Southwestern and Children's Health Medical Center. Recruitment and consent procedures may begin during ED or inpatient hospitalization; however, as the study is an outpatient study, study procedures will not begin until the participant is discharged from the ED or inpatient hospital.
Recruitment efforts will target medically healthy male and female youths with recent suicide events who are either seeking care at an emergency room, admitted to an inpatient unit, enrolled in an IOP, or receiving adequate outpatient care with either psychopharmacological or psychosocial treatment following a suicide event.
Enrollment of 114 subjects is expected to take place over a period of approximately 36 months. Enrolled participants will be involved in the study for approximately 14 weeks. Visits include a Screening Visit, 4 Study Intervention Visits, and 11 Follow-Up Visits (combination of in-person and remote visits). Multiple streams of outcome measures will be utilized for this protocol, including self-report measures, research assessor-completed measures, clinic level measures, and behavioral measures.
Aim 1. Evaluate reduction in repeat suicidal events with ketamine.
Aim 2. Evaluate reduction in implicit suicidal cognition with ketamine.
Aim 3. Evaluate reduction in depressive symptoms and suicidality with ketamine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Youth will be randomized in 1:1 fashion to either intravenous ketamine (0.5 mg/kg) or midazolam (0.02 mg/kg) twice weekly for 2 weeks followed by weekly visits for 10 weeks (for a total of 12-week post-randomization observation period).
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Active comparator | Drug: Ketamine Hydrochloride, Drug: Midazolam Hydrochloride0.5 mg/kg intravenous ketamine will be administered 4 times in a 2 week period. Ketamine will be dissolved in 0.9% sodium chloride in a total volume of 100ml and administered with a syringe infusion pump at a constant rate. |
| Midazolam | Active comparator | Drug: Ketamine Hydrochloride, Drug: Midazolam Hydrochloride0.02 mg/kg midazolam will be administered 4 times in a 2 week period. Midazolam will be dissolved in 0.9% sodium chloride in a total volume of 100ml and administered with a syringe infusion pump at a constant rate. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Be adolescents (aged 13-18 years);
- Have had a recent suicidal event (suicide attempt or significant suicidal ideation with a plan or intent warranting emergency evaluation or inpatient hospitalization within the past 90 days);
- Receiving standard of care treatment that includes clinically indicated psychosocial and/or psychopharmacological treatment;
- Have a current primary diagnosis of a depressive disorder based on the MINI-KID (other psychiatric disorders are acceptable, but must not be primary);
- Participants must be able to complete assessments in English. However, the parent(s) or legal guardians of minors may either speak English or Spanish
Key exclusion criteria (11 listed)
- Have a psychotic disorder, such as lifetime schizophrenia, or a pervasive or intellectual developmental disorder requiring substantial or very substantial support;
- Have current mania, hypomania, mixed episode, or obsessive-compulsive disorder;
- Have a primary diagnosis other than a depressive disorder;
- Have moderate to severe alcohol or substance use disorder within the past six months (based on MINI-KID); If there is a positive urine drug screen at screening, the urine drug screen will be repeated at each infusion visit. Positive urine drug screen will be reviewed by study physician and infusion will proceed as long as no safety risk was identified;
- If female, be pregnant, lactating, or nursing; Women of childbearing potential must have a negative urine pregnancy test prior to all infusions;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine HydrochlorideAlso: Ketalarinfused over a 40 minute period | Drug | Ketamine, Midazolam |
| Midazolam HydrochlorideAlso: Versedinfused over a 40 minute period | Drug | Ketamine, Midazolam |
Primary outcome
Number of Days to First Suicidal Event
Time frame: 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.
Number of Days to First Suicidal Event (by Sex)
Time frame: 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.
Number of Days to First Suicidal Event (by Ethnicity)
Time frame: 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.
Number of Days to First Suicidal Event (by Race)
Time frame: 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.
4 secondary outcomes
Death/Suicide Implicit Association Test (IAT) Score
Time frame: 2 weeks
Concise Health Risk Tracking Self-Report (CHRT-SR) Score
Time frame: 2 weeks
Percentage of Participants With Suicidal Events/Behaviors as Measured by CHRT-C a Self Report Measure
Time frame: 2 week
Inventory of Depressive Symptomatology (IDS) Self Report Score
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42849709Trivedi MH, Chin Fatt CR, Ayvaci ER, Mayes TL, Jha MK, Pak TK, Rebstock S, Spain T, Walsh D, Kimatian S, Monastirsky M, Vasu S, Carmody TJ, Minhajuddin A, Kennard BD, Emslie GJ. Randomized controlled trial of acute ketamine versus midazolam for recurrence of suicidality in adolescents (TASK): Rationale, design, and baseline characteristics. Contemp Clin Trials. 2026 Oct 8;170:108498. doi: 10.1016/j.cct.2026.108498. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Suicide, Attempted
Recruiting
Preventing Suicidal Behavior With Diverse High-Risk Youth in Acute Care Settings
Suicide, Attempted, Suicide Ideation
Active, not recruiting
Motivational Interviewing to Address Suicidal Ideation for Veterans at High Risk for Suicide
Suicide, Attempted, Suicidal Ideation
Recruiting
Suicide Preventive Psychosocial Treatment for Youths
Suicide Attempt, Suicidal and Self-injurious Behavior
Recruiting
Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression
Depressive Disorder, Major Depressive Disorder, Suicidal Ideation
Not yet recruiting
THRIVE: A Recovery-Focused Suicide Prevention Intervention in Crisis Stabilization Centers
Suicide
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhukar Trivedi, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketamine Hydrochloride and Midazolam Hydrochloride in people with Suicide, Attempted and Suicide and Depression, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Days to First Suicidal Event (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04592809, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.