Nebulized ketamine treatment for major depression in hospitalized patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of nebulized ketamine as a treatment for individuals with moderate to severe depression who are currently hospitalized. It is a double-blind, placebo-controlled study where participants will receive either nebulized ketamine or an active placebo, Midazolam, during their inpatient stay. Participants will undergo a series of visits, with dosing days requiring in-person attendance for monitoring. The study aims to assess the reduction of depressive symptoms through this innovative delivery method of ketamine.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* All individuals 18 years and older with a Montgomery-Asberg Depression Rating Scale score (MADRS) ≥ 20
* Must have a diagnosis of moderate to severe Major Depressive Disorder (MDD)
* Structured Clinical Interview for DSM-5 (SCID-5) will be performed to confirm MDD diagnosis

Exclusion Criteria:

* Adult patients with an allergy to Ketamine
* Adult patients with an allergy to Midazolam
* Individuals with a history of mania/hypomania or diagnosis 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

Where it's running

• Maimonides Medical Center
  Brooklyn, New York, United States Recruiting

Study contacts

• Study coordinator: Jessica Poster, MD
• Email: JPoster@maimo.org
• Phone: 718-283-8170

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.