RecruitingPhase 3NCT06752759

Nebulized Ketamine for the Treatment of Major Depressive Disorder

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


Sponsor

Theresa Jacob, PhD, MPH

Enrollment

40 participants

Start Date

Oct 16, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 88 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether nebulized (inhaled mist) ketamine — given in a low dose through a breathing mask — is a safe and effective treatment for hospitalized patients with moderate to severe major depressive disorder (MDD). **You may be eligible if...** - You are 18 or older and currently hospitalized in a psychiatric unit - You have a confirmed diagnosis of moderate to severe major depression (MDD) - Your depression score on a standard rating scale is 20 or above **You may NOT be eligible if...** - You have an allergy to ketamine or midazolam - You have bipolar disorder (history of mania or hypomania) - You have a psychotic disorder (including MDD with psychotic features) - You have a substance use disorder (other than nicotine or caffeine) in the past 3 months - You have PTSD, OCD, borderline or antisocial personality disorder, or intellectual disability - You have uncontrolled high blood pressure or congestive heart failure - You weigh more than 150 kg - You are currently on lithium or lamotrigine, or on more than 2 blood pressure medications - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGnebulized 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).

DRUGnebulized 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).


Locations(1)

Maimonides Medical Center

Brooklyn, New York, United States

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NCT06752759


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