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

This triple-blind, placebo-controlled trial (n=40) will assess the effects of nebulized ketamine (105mg/70kg) on depressive symptoms in adult inpatients with moderate to severe depression. An active placebo, midazolam (2.1mg/70kg), will be used for comparison.

The study, sponsored by Dr. Theresa Jacob, PhD, MPH, at Maimonides Medical Center, aims to evaluate the potential of inhaled ketamine as an adjunct treatment for major depressive disorder (MDD).

Participants, aged 18 and older, will be randomized into either the ketamine or midazolam group and will undergo 4 to 5 study visits. Dosing days will require in-person participation, where individuals will be monitored for at least two hours post-administration. Researchers will assess changes in depression severity using the Montgomery-Åsberg Depression Rating Scale (MADRS) over an 8- to 10-day period. Additional measures will include suicide ideation (Beck Scale), dissociative symptoms (CADSS), sedation levels (MOAA/S, RASS), and side effects (SERSDA). The trial is expected to complete primary data collection by September 2026.

Trial Details

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 enrolment by the study.

Trial Number NCT06752759

Data attribution

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