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

What this Trial Is About

Researchers are evaluating the use of nebulized ketamine as a treatment for adults with moderate to severe depression in an inpatient psychiatric setting. This double-blind, randomized clinical trial compares nebulized ketamine with an active placebo, midazolam, to assess their effects on depressive symptoms. The study is designed to provide insights on whether inhaled ketamine can reduce depression when added to current medications and therapies. Participants will be randomly assigned to receive either nebulized ketamine at a dose calculated by body weight (1.5 mg/kg) or nebulized midazolam as an active comparator (0.03 mg/kg). The study involves 4 to 5 visits depending on the treatment group, with dosing days requiring in-person attendance and monitoring for at least two hours. All other visits can be conducted remotely. Vital signs will be regularly collected during the observation period following dosing. Adults aged 18 and older diagnosed with moderate to severe major depressive disorder will be screened and enrolled. Throughout the 8 to 10 day study period, researchers will measure changes in depression using the Montgomery-Åsberg Depression Rating Scale (MADRS) and other scales assessing suicide ideation, dissociative effects, sedation, and agitation. Safety monitoring includes vital signs and side effect assessments. The study aims to capture both immediate and short-term effects of the treatments on depressive symptoms.

Nebulized Ketamine for the Treatment of Major Depressive Disorder