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RecruitingPhase 3

Nebulized Ketamine for the Treatment of Major Depressive Disorder

NCT06752759 · Theresa Jacob, PhD, MPH

Recruiting
Status
Accepting participants
Phase 3
Phase
40
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS)

    Measured over 8-10 days

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 88 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * All individuals 18 years and older with a Montgomery-Asberg Depression Rating Scale score (MADRS) ≥ 20 * Must have a diagnosis of moderate to severe Major Depressive Disorder (MDD) * Structured Clinical Interview for DSM-5 (SCID-5) will be performed to confirm MDD diagnosis Exclusion Criteria: * Adult patients with an allergy to Ketamine * Adult patients with an allergy to Midazolam * Individuals with a history of mania/hypomania or diagnosis of bipolar disorder * Patients on lithium and/or lamotrigine therapy * Recent or current homicidal ideation with an intent to act * MDD with psychotic features or current or past diagnosis of a psychotic disorder * No substance use disorder in the preceding 3 months except nicotine or caffeine or a positive urine screen for substances (except cannabis) * Diagnosis of obsessive-compulsive disorder, antisocial personality disorder, borderline personality disorder, posttraumatic stress disorder, intellectual disability, altered mental status, pregnant or breastfeeding patients, * Patients on \> 2 medications for hypertension * Patients with uncontrolled hypertension (BP \>140 mm Hg systolic and/or \>90 mm Hg diastolic on two separate readings at the time of screening) * Body weight of \> 150kg * Patients with history of congestive cardiac failure * Day of presentation, patients with unstable vital signs (systolic blood pressure \<90 or\>160 mm Hg, pulse rate \<50 or \>150 beats/min, and respiration rate \<10 or \>30 breaths/min) * Consumption of opioids within 24 hours of drug administration * Acutely intoxicated patients will also be excluded

Where

1 study site

FacilityCityRegionCountry
Maimonides Medical CenterBrooklynNew YorkUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06752759 on ClinicalTrials.gov →

Last updated in the registry 2026-04-24. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits