Actively Recruiting

Phase 3
Age: 18Years - 88Years
All Genders
NCT06752759

Nebulized Ketamine for the Treatment of Major Depressive Disorder

Led by Theresa Jacob, PhD, MPH · Updated on 2026-04-24

40

Participants Needed

1

Research Sites

154 weeks

Total Duration

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AI-Summary

What this Trial Is About

This is a double-blind active placebo controlled clinical trial for individuals with moderate to severe depression. The purpose of this study is to assess if nebulized ketamine can reduce depressive symptoms.

CONDITIONS

Official Title

Nebulized Ketamine for the Treatment of Major Depressive Disorder

Who Can Participate

Age: 18Years - 88Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals 18 years or older with a Montgomery-Åsberg Depression Rating Scale score of 20 or higher
  • Diagnosis of moderate to severe Major Depressive Disorder confirmed by Structured Clinical Interview for DSM-5
Not Eligible

You will not qualify if you...

  • Allergy to ketamine or midazolam
  • History of mania, hypomania, or bipolar disorder
  • Currently taking lithium or lamotrigine
  • Recent or current homicidal ideation with intent
  • Major depressive disorder with psychotic features or diagnosis of psychotic disorder
  • Substance use disorder in past 3 months (except nicotine, caffeine, or cannabis)
  • Diagnosis of obsessive-compulsive disorder, antisocial personality disorder, borderline personality disorder, posttraumatic stress disorder, or intellectual disability
  • Altered mental status
  • Pregnant or breastfeeding
  • Taking more than 2 medications for hypertension
  • Uncontrolled hypertension (blood pressure over 140/90 mm Hg on two readings)
  • Body weight over 150 kg
  • History of congestive heart failure
  • Unstable vital signs at screening (specific blood pressure, pulse, or respiration thresholds)
  • Opioid use within 24 hours before drug administration
  • Acutely intoxicated patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Maimonides Medical Center

Brooklyn, New York, United States, 11219

Actively Recruiting

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Research Team

J

Jessica Poster, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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