RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-10-16

Study Completion:2026-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06752759

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.

Ages Eligible for Study:18 Years to 88 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Locations (Sites)

Maimonides Medical Center

Brooklyn, New York, 11219

United States

Collaborators and Investigators

Sponsor: Theresa Jacob, PhD, MPH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-16

Study Completion Date2026-09-30

Study Record Updates