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NMDA Receptor Antagonist

Ketamine vs Midazolam for Suicidal Thoughts

Phase 3
Recruiting
Led By Madhukar Trivedi, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a current primary diagnosis of a depressive disorder based on the MINI-KID (other psychiatric disorders are acceptable, but must not be primary)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial will test if ketamine/midazolam is more effective than a placebo at reducing suicidal thoughts in adolescents with recent suicidal behaviors.

Who is the study for?
Adolescents aged 13-18 with recent suicidal behavior and a primary diagnosis of depression are eligible. They must be fluent in English, not have severe substance use issues or unstable medical conditions, and agree to use contraception. Those with certain psychiatric disorders or weighing over 120 kilograms are excluded.Check my eligibility
What is being tested?
The trial is testing the effectiveness of ketamine compared to midazolam in reducing suicidality among adolescents receiving standard care for depression. It's a double-blind study where treatments are given twice weekly initially, then assessed weekly up to week 12.See study design
What are the potential side effects?
Ketamine may cause dissociation, dizziness, nausea, increased blood pressure and heart rate; Midazolam can induce sleepiness, memory issues, and coordination problems. Both drugs will be monitored for any adverse effects during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My main diagnosis is depression.
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I am using or will use effective birth control during and for 3 months after treatment.
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I am between 13 and 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The for the study is "suicidal events". Suicidal event is defined as a suicide attempt, or emergency department visit or inpatient hospitalization due to suicidality.
Secondary outcome measures
Death/Suicide Implicit Association Test (IAT)
Depression symptoms as measured by CHRT-SR a self report measure
Depression symptoms as measured by the Inventory of Depressive Symptomatology (IDS), Parent self report measure
+2 more

Trial Design

2Treatment groups
Active Control
Group I: MidazolamActive Control2 Interventions
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.
Group II: KetamineActive Control2 Interventions
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.

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,053,511 Total Patients Enrolled
45 Trials studying Depression
19,133 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,503 Total Patients Enrolled
666 Trials studying Depression
251,320 Patients Enrolled for Depression
Madhukar Trivedi, MDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center
14 Previous Clinical Trials
10,812 Total Patients Enrolled
8 Trials studying Depression
9,522 Patients Enrolled for Depression

Media Library

Depression Research Study Groups: Midazolam, Ketamine
Depression Clinical Trial 2023: Ketamine Hydrochloride Highlights & Side Effects. Trial Name: NCT04592809 — Phase 3
Ketamine Hydrochloride (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04592809 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the normal use of Midazolam?

"Midazolam is often used to control seizures in epileptic patients, but it can also be helpful for those struggling with amnesia or who need to undergo a therapeutic procedure."

Answered by AI

Are elderly individuals being sought out for this experiment?

"The age bracket for participants in this clinical trial is 13-18 years old."

Answered by AI

Is Midazolam use well-tolerated in most people?

"Midazolam's safety is estimated to be a 3. This assessment comes from the fact that midazolam is in Phase 3 clinical trials. At this point, there is some data supporting efficacy as well as multiple rounds of data affirming safety."

Answered by AI

Are there any current opportunities to participate in this clinical trial?

"The trial is still open and actively recruiting patients, according to the clinicaltrials.gov listing. This particular study was originally posted on October 3rd, 20202 and received its most recent update November 3rd, 20202."

Answered by AI

Who else is applying?

What site did they apply to?
UT Southwestern Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I feel hopeless and I want my life back on track.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

What is the process?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents
Madhukar H. Trivedi, MD 2022. "Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04592809.
All > Depression Dallas
~151 spots leftby May 2026
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