Status:
Enrolling
Nebulized Ketamine for the Treatment of Major Depressive Disorder in an Inpatient Setting
Phase
III
Age
18-88
Sponsor
Theresa Jacob, PhD, MPH
Enrollment code
40
Last Updated
Mar 25, 2025
Locations
1 Country
Overview
Condition/disease
Depression
Modalities
Anesthetics
Trial drugs
ketamine
Clinicaltrials.gov ID
Brief 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.
Trial locations
Found 1 site
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 plan
Active Comparator: Nebulized Midazolam
Midazolam used as active placebo. Dosage calculated by body weight at 0.03mg/kg
Drug
nebulized ketamine
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).
Experimental: Nebulized Ketamine
Ketamine dosage calculated by body weight at 1.5mg/kg
Drug
nebulized ketamine
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).
Allocation: Randomized
Outcome measures
Primary outcome measures
- Change in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS) (8-10 days)
Secondary outcome measures
- A change in depressive symptoms on the Montgomery-Åsberg Depression Rating Scale (MADRS) from the baseline (pre-dose on day 1) and 2 hours post-medication administration (8-10 days)
- Change in Beck Scale for Suicide Ideation (24 hours)
More information
Official title
Nebulized Ketamine for the Treatment of Major Depressive Disorder in an Inpatient Setting: A Midazolam-controlled Randomized Controlled Trial
Estimated trial completion date
Sep 30, 2026
Not finding what you’re looking for?
If you’re having trouble using this website or can’t find what you’re looking for, please call us at 1-855-329-5969. Our team is here to help you find your way.
