Nebulized Ketamine for the Treatment of Major Depressive Disorder in an Inpatient Setting: A Midazolam-controlled Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 88
Healthy Volunteers: f
View:
• 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
Locations
United States
New York
Maimonides Medical Center
RECRUITING
Brooklyn
Time Frame
Start Date: 2024-10-16
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 40
Treatments
Active_comparator: Nebulized Midazolam
Midazolam used as active placebo. Dosage calculated by body weight at 0.03mg/kg
Experimental: Nebulized Ketamine
Ketamine dosage calculated by body weight at 1.5mg/kg
Related Therapeutic Areas
Sponsors
Leads: Theresa Jacob, PhD, MPH