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

Description

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.

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Severe Depression
Intervention / Treatment

-

Contacts and Locations

Brooklyn

Maimonides Medical Center, Brooklyn, New York, United States, 11219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * All individuals 18 years and older within the Institution's inpatient Psychiatry Unit with a Montgomery-Asberg Depression Rating Scale score ≥ 20
  • * Must have a diagnosis of moderate to severe Major Depressive Disorder
  • * Structured Clinical Interview for DSM-5 (SCID-5) will be performed to confirm MDD diagnosis
  • * Adult patients with an allergy to ketamine
  • * Adult patients with an allergy to Midazolam
  • * Individuals with a history of mania/hypomania or diagnosis of 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

Ages Eligible for Study

18 Years to 88 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Theresa Jacob, PhD, MPH,

Study Record Dates

2026-09-30