RecruitingPhase 3ketamine
Nebulized Ketamine for the Treatment of Major Depressive Disorder in an Inpatient Setting
Sponsored by Theresa Jacob, PhD, MPH
NCT ID
NCT06752759
Target Enrollment
40 participants
Start Date
2024-10-16
Est. Completion
2026-09-30
About This Study
This is a double blind active placebo controlled clinical trial for individuals within an inpatient setting with moderate to severe depression. The purpose of this study is to assess if nebulized ketamine can reduce depressive symptoms.
Conditions Studied
Interventions
- •nebulized ketamine
Eligibility
Age:18 Years - 88 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: * All individuals 18 years and older within the Institution's inpatient Psychiatry Unit with a Montgomery-Asberg Depression Rating Scale score ≥ 20 * Must have a diagnosis of moderate to severe Major Depressive Disorder * 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 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
Study Locations (1)
Maimonides Medical Center
Brooklyn, New York, United States