Nebulized Ketamine for the Treatment of Major Depressive Disorder

Recruiting now · Phase 3

Conditions studied: Severe Depression, Moderate Depression, Ketamine, Midazolam, Peripheral Nervous System Agents, Central Nervous System Agents, Neurotransmitter Agents, Physiologic Effects of Drugs, Sensory System Agents, Analgesics, Non-Narcotic, Anti-Inflammatory Agents, Non-Steroidal, Depressive Symptom, Hypnotics and Sedatives, Anti-anxiety Agents, Tranquilizing Agents, Psychotropic Drugs, Anesthetics Agent

In brief

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.

Key facts

Study ID: NCT06752759
Run by: Theresa Jacob, PhD, MPH
People needed: 40
Starts: 2024-10-16
Expected to finish: 2027-09-30
Last updated by the study team: 2026-04-24

Who can join

Age: 18 and older, up to 88. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 it is running

Maimonides Medical Center — Brooklyn, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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