NCT06752759RecruitingPhase 3
Nebulized Ketamine for the Treatment of Major Depressive Disorder
Nebulized Ketamine for the Treatment of Major Depressive Disorder in an Inpatient Setting: A Midazolam-controlled Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 23 Dec 2024
- Start date
- 16 Oct 2024
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Theresa Jacob, PhD, MPH
- Diseases
- Depression
- NCT number
- NCT06752759
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 40
- From 16 Oct 2024 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients on lithium and/or lamotrigine therapy
- Consumption of opioids within 24 hours of drug administration
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 88 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maimonides Medical Center Coordinator of this site? Confirm its status | Brooklyn | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.