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
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;
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- 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.
- 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