Theresa Jacob, PhD, MPH
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.
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, h…
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 ac…
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).
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).
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