Nebulized Ketamine for the Treatment of Major Depressive Disorder

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.

Conditions

• 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

Interventions

DRUG

nebulized ketamine

The formulation of the study drug is administered via nebulizer in which the participants inhales the study drug. The dosage is calculated by body weight (1.5mg/kg).

DRUG

nebulized midazolam

The formulation of the active comparator drug is administered via nebulizer in which the participant inhales the study drug. The dosage is calculated by body weight (0.03mg/kg).

Sponsors & Collaborators

• Theresa Jacob, PhD, MPH

  lead OTHER

Principal Investigators

• Theresa Jacob, PhD, MPH · Maimonides Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

88 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-16

Primary Completion

2027-09-30

Completion

2027-09-30

FDA Drug

Yes

Countries

• United States

Study Locations