NCT06752759

Nebulized Ketamine for the Treatment of Major Depressive Disorder in an Inpatient Setting

Nebulized Ketamine for the Treatment of Major Depressive Disorder in an Inpatient Setting: A Midazolam-controlled Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Theresa Jacob, PhD, MPH · Academic / Other
• Sex: All
• Age: 18 Years – 88 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The objective of this study is to evaluate the effect of ketamine formalized to be dispensed via inhalation, as an adjunct to concomitant medications and therapies on those with moderate to severe depression currently in an inpatient psychiatric unit. Investigators will examine the effects of nebulized ketamine on depressive symptoms. This is a prospective double-blind placebo controlled study in which an active placebo, Midazolam, will be used. Participants will commit to either 4 visits or 5 visits depending on which treatment arm they are randomized into. All visits can be done remotely, however, days in which the participant will be dosed will have to be in person. During dosing days, the participant will be monitored for a minimum of two hours. Study participant's vitals will be collected at regular intervals during the observation period. Adult psychiatry inpatients who are 18 years and older with a diagnosis of moderate to severe depression will be screened for enrollment by the study.

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
• GABA Modulators
• GABA Agents

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2024-10-16
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2024-12-31
• Last updated: 2024-12-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study