Nebulized ketamine compared with midazolam for adults with depression
Tests inhaled ketamine against midazolam in adults with moderate to severe depression.
Plain-language title generated from the registry record
Registry title: Nebulized Ketamine for the Treatment of Major Depressive Disorder
Key facts
- Where
- Brooklyn, United StatesSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 88 years old?
Source: NCT06752759, who can take part
Where in United States
- Maimonides Medical CenterBrooklyn, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Theresa Jacob, PhD, MPH
- Trial code
- NCT06752759
- Record updated
- 24 April 2026
- Original description
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.Read full original descriptionShow less
Nebulized Ketamine for the Treatment of Major Depressive Disorder in an Inpatient Setting: A Midazolam-controlled Randomized Controlled Trial
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.
Inclusion: 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: Patients on lithium and/or lamotrigine therapy; Consumption of opioids within 24 hours of drug administration; 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; 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); Patients with history of congestive cardiac failure; Recent or current homicidal ideation with an intent to act; Body weight of > 150kg; 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); Acutely intoxicated patients will also be excluded.