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NMDA Receptor Antagonist

Esketamine vs. Ketamine for Depression

New Haven, CT

Phase 3

Recruiting

Led By Samuel Wilkinson, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate or severe depression based on an initial MADRS score ≥ 25

Diagnosis of major depressive disorder that is refractory to two or more antidepressant trials

Must not have

Uncontrolled hypertension

Diagnosis of bipolar disorder or psychotic disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to compare the effectiveness, acceptability, and side effects of ketamine delivered through an IV and Esketamine taken as a nasal spray for treating treatment-resistant depression. Researchers will assess how

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Who is the study for?

This trial is for individuals with treatment-resistant depression (TRD), meaning their depression hasn't improved after trying other treatments. Participants must be comfortable receiving medication through an IV or as a nasal spray. Specific eligibility criteria are not provided, but typically include factors like age, health status, and prior treatments.Check my eligibility

What is being tested?

The study compares two forms of ketamine: IV racemic ketamine, which isn't FDA-approved for TRD yet, and Esketamine (Spravato®) nasal spray, which is approved. It will assess how effective they are at easing symptoms of depression, patient comfort with the treatments, and side effect management.See study design

What are the potential side effects?

While specific side effects aren't listed here, both forms of ketamine can cause dissociation (feeling disconnected from yourself), dizziness, nausea, increased blood pressure, sedation (feeling sleepy or less alert), and potential for abuse or dependency.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have moderate to severe depression.

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My depression hasn't improved after trying two different antidepressants.

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Exclusion Criteria

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

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My blood pressure is not well-controlled.

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I have been diagnosed with bipolar disorder or a psychotic disorder.

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I have had a brain bleed or an aneurysm.

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I have an arteriovenous malformation.

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I have a condition that makes high blood pressure dangerous for me.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Self-Reported Effectiveness

Secondary study objectives

Acceptability

Clinician-Reported Effectiveness

Level of Disability

+7 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

Experimental Treatment

Group I: Spravato (Esketamine)Experimental Treatment1 Intervention

Spravato® (Esketamine) will be given intranasally. For esketamine, the dose will be between 56 and 84mg, according to the FDA label for the drug. Allowances will be made for patients who have difficulty tolerating these doses to be dosed at 28mg in subsequent treatment sessions.

Group II: Racemic KetamineExperimental Treatment1 Intervention

Ketamine will be given intravenously. Per FDA guidance, the max dose of ketamine will be 60mg per day, with a total lifetime limit of 8 doses. Ketamine will be infused over 40 minutes.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Racemic ketamine

2011

N/A

~20

0 / 7Eligibility criteria met