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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

Must not have

Have a primary diagnosis other than a depressive disorder

If female, be pregnant, lactating, or nursing. Women of childbearing potential must have a negative urine pregnancy test prior to all infusions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My primary diagnosis is not depression.

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I am not pregnant, breastfeeding, and have a negative pregnancy test.

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I have been treated for depression with ketamine, esketamine, or midazolam, or cannot take them due to health reasons.

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I weigh more than 120 kilograms.

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I am currently experiencing mania, hypomania, mixed episodes, or OCD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 8Eligibility criteria met